Clinical Trials Actively Recruiting

Having a large clinical trial portfolio means giving patients treatment options often not available anywhere else, and years before they become the standard of care. To learn more about Karmanos Cancer Institute clinical trials or to see if a trial is right for you, please call 1-800-KARMANOS (1-800-527-6266) or request an appointment below.

Request an Appointment Refer a Patient NCI Dictionary of Cancer Terms Clinical Trials App

Hide Search Criteria

Cancer Category

Enter Keyword

Clinical Trial Phase

Therapies Involved

Device Involved

Study Site

NCT ID

KCI Trial ID

Drug Involved

Principal Investigator

Clear Search

Results 1 - 10 of 64

A Global Multicenter, Open Label, Randomized, Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients with Chronic Phase Chronic Myeloid Leukemia (POLARIS-2)
Objective:

Part A

Primary Objective:

To compare the MMR rate at 24 weeks for olverembatinib versus bosutinib

Secondary Objectives:

To compare the MMR rate at 96 weeks for olverembatinib versus bosutinib

To compare additional parameters of the efficacy of olverembatinib versus bosutinib

To compare the safety profile of olverembatinib versus bosutinib

To characterize the Population PK of olverembatinib in the CML-CP population

To evaluate Patient-Reported Outcome (PRO) measures of olverembatinib

To evaluate Health Economics Outcomes Research (HEOR) measures of olverembatinib

Part B

Primary Objective:

To evaluate the MMR rate by 24 weeks of olverembatinib in CML-CP patients with T315I mutation

Secondary Objectives:

To evaluate the MMR rate by 96 weeks of olverembatinib in CML-CP patients with T315I mutation

To compare additional parameters of the efficacy of olverembatinib in CML-CP patients with T315I mutation

To evaluate the safety profile of olverembatinib in CML-CP patients with T315I mutation

To characterize the population PK of olverembatinib in the CML-CP population with T315I mutation

To evaluate PRO measures of olverembatinib

To evaluate HEOR measures of olverembatinib
Cancer Categories:
Hematologic (Blood Cancers)
Principal Investigator:
Yang, Jay
Karmanos Trial ID:
2025-006
Age Group:
Adult
Phase:
Phase III
Learn More
A Phase II Trial of Non-Myeloablative Conditioning and Transplantation of Haploidentical Related, Partially HLA-Mismatched, or Matched Unrelated Bone Marrow for Newly Diagnosed Patients with Severe Aplastic Anemia
Objective:

Primary Objective:

Estimate GVHD-free failure-free survival (GFFS) (a composite end point of survival without Grade III-IV aGVHD, cGVHD requiring immunosuppression, or primary or secondary graft failure requiring second definitive therapy) at 1 year after initiation of conditioning. GFFS will be evaluated separately for each transplant cohort.

Secondary Objectives:

Estimate OS at 1 year after initiation of conditioning.

Estimate FFS (a composite end point of survival without initiation of treatment with a second definitive therapy for curative intent) at 1 year after initiation of conditioning.

Estimate the probability of being engrafted (i.e., without primary or secondary graft failure) and alive at 1 year after initiation of conditioning.

Estimate the cumulative incidences of neutrophil recovery at Day +28 and Day +56 post-HSCT, platelet recovery at Day +100 post-HSCT, and red blood cell recovery at Day +100, Day +180, and Day +365 post-HSCT.

Estimate the cumulative incidences of primary, secondary, and any graft failure at 1 year post-HSCT.

Estimate the hematologic response classification according to the NIH criteria at Day +100, Day +180, and Day +365 post-HSCT.

Estimate the cumulative incidences of Grade II-IV and Grade III-IV aGVHD at Day +100 post-HSCT.

Estimate the cumulative incidences of all cGVHD and cGVHD requiring immunosuppression at 1 year post-HSCT.
Cancer Categories:
Hematologic (Blood Cancers)
Principal Investigator:
Uberti, Joseph
Karmanos Trial ID:
BMTCTN2207
Age Group:
Adult
Phase:
Phase II
Learn More
A Phase III Randomized Trial for Newly Diagnosed Multiple Myeloma (NDMM) Patients Considered Frail or in a Subset of Intermediate Fit Comparing Upfront Three-Drug Induction Regimens Followed by Double- or Single-Agent Maintenance
Objective:

Dual Primary Objectives:

To compare progression-free survival (PFS) in frail or selected intermediate fit
Newly Diagnosed Multiple Myeloma (NDMM) participants treated with VRd-Lite
induction followed by Lenalidomide maintenance (Arm 1) versus DRd induction
followed by Lenalidomide maintenance (Arm 2).

To compare overall survival (OS) in frail or selected intermediate fit NDMM
participants treated with VRd-Lite induction followed by lenalidomide maintenance
(Arm 1) versus DRd induction followed by lenalidomide and daratumumab and
hyaluronidase-fihj maintenance (Arm 3).

Secondary Objectives

To compare PFS in Arm 1 versus Arm 3

To compare OS in Arm 1 versus Arm 2.

To compare OS in Arm 2 versus Arm 3, contingent upon significant results from both dual primary endpoints in favor of the respective experimental arms.

To compare the overall response rate (ORR) of Arm 1 against the ORR of Arm 2 and Arm 3.

To assess the safety of Arm 1 with the safety of Arm 2 and Arm 3.

To explore veinous and arterial thrombo-embolism (VTE) incidence in participants receiving lenalidomide during induction across the three study arms.

To describe median time to response (CR or better per IMWG criteria, VGPR or better per IMWG criteria, PR or better per IMWG criteria) on the three study arms.
Cancer Categories:
Hematologic (Blood Cancers)
Principal Investigator:
Cole, Craig
Karmanos Trial ID:
S2209
Age Group:
Adult
Phase:
Phase III
Learn More
A Phase III Randomized Trial of Steroids +Tyrosine Kinase Inhibitor Induction with Chemotherapy or Blinatumomab for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults
Objective:

Primary Objectives:

To compare the overall survival (OS) following induction with steroids + TKI + blinatumomab versus induction with steroids + TKI + chemotherapy.

Secondary Objectives:

To compare the rate of MRD negativity for patients treated with chemotherapy vs blinatumomab at the end of first induction (week 15).

To evaluate the rate of the MRD negativity by treatment arm for those patients MRD positive after the first induction and administered of second induction.

To compare event free survival (EFS) for patients initially randomized for chemotherapy vs blinatumomab. (Events include failure to achieve induction molecular remission by week 15, confirmed molecular relapse after molecular remission or to death in remission).

To assess the toxicities of blinatumomab+TKI and steroids + TKI + chemotherapy in this patient population.

To assess the toxicities of the chemotherapy regimen in this patient population.

To describe the outcome of patients who proceed to allogeneic stem cell transplant after treatment with blinatumomab+TKI only.
Cancer Categories:
Hematologic (Blood Cancers)
Principal Investigator:
Yang, Jay
Karmanos Trial ID:
EA9181
Age Group:
Adult
Phase:
Phase III
Learn More
A Phase III, Randomized Study of Daratumumab, Cyclophosphamide, Bortezomib and Dexamethasone (DARA-VCD) Induction Followed by Autologous Stem Cell Transplant or DARA-VCD Consolidation and Daratumumab Maintenance in patients with Newly Diagnosed AL Amyloidosis
Objective:

Primary Objective:

To compare major organ deterioration progression-free survival between participants randomized to the ASCT and non-ASCT arms of this study.

Secondary Objectives

To compare overall survival (OS) between participants randomized to the ASCT and non-ASCT arms of this study.

To compare rates of cardiac and renal organ responses between participants randomized to the ASCT and non-ASCT arms of this study.

To compare rates of cardiac and renal organ progression between participants randomized to the ASCT and non-ASCT arms of the study.

To compare the frequency and severity of toxicities between participants randomized to the ASCT and non-ASCT arms of this study.

To compare minimal residual disease (MRD) negativity rates between participants randomized to the ASCT and non-ACST arms of this study.
Cancer Categories:
Hematologic (Blood Cancers)
Principal Investigator:
Kin, Andrew
Karmanos Trial ID:
S2213
Age Group:
Adult
Phase:
Phase III
Learn More
A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy with Immuno-oncology Therapy for Children and Adults with Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma
Objective:

Primary Objectives:

To compare the PFS of a standard chemotherapy approach versus an IO therapy approach (brentuximab vedotin and nivolumab) in patients with newly diagnosed early stage cHL who have a rapid early response (RER) as determined by PET2 after 2 cycles of doxorubicin, bleomycin, vinblastine, dacarbazine (ABVD) chemotherapy.

To compare the PFS of a standard chemotherapy approach versus an IO therapy approach (brentuximab vedotin and nivolumab) plus involved site radiation therapy (ISRT) in patients with newly diagnosed early stage cHL who have a slow early response (SER) as determined by PET2 after 2 cycles of ABVD chemotherapy.

Secondary Objectives:

To demonstrate non-inferiority of overall survival (OS) at 12 years of IO therapy versus standard therapy in early stage cHL patients who have a RER as determined by PET2 after 2 cycles of doxorubicin, bleomycin, vinblastine, dacarbazine (ABVD) chemotherapy.

To evaluate the overall survival (OS) at 12 years of IO therapy versus standard therapy in early stage cHL patients who have a SER as determined by PET2 after 2 cycles of doxorubicin, bleomycin, vinblastine, dacarbazine (ABVD) chemotherapy.

To demonstrate non-inferiority of overall survival (OS) at 12 years of IO therapy versus standard therapy in early stage cHL patients.

To evaluate in patients with newly diagnosed early stage cHL the PFS of a standard chemotherapy approach versus an IO therapy approach (brentuximab vedotin and nivolumab) in the overall cohort, in the favorable risk cohort, and in the unfavorable risk cohort.

To evaluate the EFS at 12 years of patients undergoing standard chemotherapy versus an IO therapy approach (brentuximab vedotin and nivolumab). 1.2.6 To compare the physician-reported treatment-related adverse event (AE) rates between a standard chemotherapy approach and an IO therapy approach (brentuximab vedotin and nivolumab) in patients with newly diagnosed early stage cHL.

To compare patient-reported adverse events using pediatric and adult versions of Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), stratified by age groups, therapeutic arms, and receipt of RT over time.

To evaluate changes in patient-reported fatigue, cognitive functioning, and health-related quality of life (HRQoL), e.g., emotional, physical, and role functioning, by treatment arm, using validated adult and pediatric measurement systems.

To evaluate self-reported late morbidities (e.g., cardiovascular, pulmonary and endocrine) over time for children, adolescents and adults undergoing standard chemotherapy versus an IO therapy approach (brentuximab vedotin and nivolumab) with and without RT using measures from the St. Jude Lifetime Cohort Study (SJLIFE).

To evaluate FDG-PET measurements of metabolic tumor burden (MTV and TLG) at PET1 as a predictive marker of PFS. 1.2.11 To evaluate the associations between race/ethnicity and key outcomes including early response to therapy, PFS and OS.
Cancer Categories:
Hematologic (Blood Cancers)
Principal Investigator:
Modi, Dipenkumar
Karmanos Trial ID:
AHOD2131
Age Group:
Both
Phase:
Phase III
Learn More
A Randomized Phase 3 Trial of Continuous vs. Intermittent Maintenance Therapy with Zanubrutinib as Upfront Treatment in Older Patients with Mantle Cell Lymphoma
Objective:

Primary objective:

To compare time to first progression or death (PFS1) with continuous treatment (Arm A) and time to second progression or death (PFS2) with intermittent treatment that is restarted at first progression (Arm B). PFS1 and PFS2 will be defined as follows for patients who achieve complete remission (CR) with induction therapy and are randomized to a maintenance treatment arm:

Continuous treatment Arm A: time from randomization until first progression or death from any cause (PFS1)

Intermittent treatment Arm B: time from randomization until second progression or death from any cause (PFS2)

Key secondary objective:

To compare overall survival between patients who achieve a CR with induction therapy subsequently treated with continuous treatment vs. intermittent treatment as part of maintenance therapy.

Secondary objectives:

To determine overall response rate (ORR) and CR rate to induction therapy with zanubrutinib and rituximab in previously untreated MCL

To determine adverse events during induction and post-induction in each study arm (Arm A and B) by CTCAE 5.0

To determine PFS1, event free survival (EFS) and overall survival (OS) in each study arm (A and B)

To determine the overall response rate (ORR) and complete response rate (CR) after restarting zanubrutinib, following the first progression, in the intermittent treatment arm (Arm B)

To compare burden of symptomatic AEs as assessed by PRO-CTCAE between patients randomized to Arm A versus Arm B.
Cancer Categories:
Hematologic (Blood Cancers)
Principal Investigator:
Modi, Dipenkumar
Karmanos Trial ID:
A052101
Age Group:
Adult
Phase:
Phase III
Learn More
A Randomized Phase II Study Comparing Cytarabine + Daunorubicin (7 + 3) vs (Daunorubicin and Cytarabine) Liposome, Cytarabine + Daunorubicin + Venetoclax, Azacitidine + Venetoclax, and (Daunorubicin and Cytarabine) Liposome + Venetoclax in Patients Aged 59 or Younger Who are Considered High-Risk (Adverse) Acute Myeloid Leukemia As Determined by MYELOMATCH; A MYELOMATCH Clinical Trial
Objective:

Primary Objectives:

To compare measurable residual disease (MRD) negative complete remission (CR) rates between each of the experimental regimens and Cytarabine + Daunorubicin (7+3).

Secondary Objective:

To estimate the frequency and severity of toxicities with each of the regimens.

To estimate complete remission (CR) rates, complete remission with incomplete count recovery (CRi, with and without MRD) rates, event-free survival (EFS), time to relapse, relapse-free survival (RFS), and overall survival (OS) with each of the regimens.

To describe and compare MRD negative CR rates by genomic subgroups within and across randomized arms.
Cancer Categories:
Hematologic (Blood Cancers)
Principal Investigator:
Singh, Vijendra
Karmanos Trial ID:
MM1YA-S01
Age Group:
Adult
Phase:
Phase II
Learn More
A Randomized Phase II trial of consolidation therapy following CD19 CAR T-cell treatment for Relapsed/Refractory Large B-cell Lymphoma or Grade IIIB Follicular Lymphoma
Objective:

Primary Objectives:

To compare the progression-free survival in participants with relapsed/refractory
large B-cell lymphoma or follicular lymphoma grade 3B with stable disease (SD)
or partial remission (PR) on first imaging response by central review (day +30
PET/CT scan) after commercial CD19 CAR T-cell therapy who are randomized to
receive each consolidation therapy versus those that receive no consolidation
therapy (i.e. control). Specifically, to compare the PFS of 1) mosunetuzumab
consolidation to no consolidation, 2) polatuzumab vedotin consolidation to no
consolidation, 3) mosunetuzumab + polatuzumab vedotin to no consolidation

Secondary Objectives:

To compare overall survival (OS) in participants randomized to each consolidation
treatment arm versus control.

To compare the complete remission (CR) conversion rate up to one year in
participants randomized to each consolidation arm versus control.

To evaluate the treatment-related adverse events in participants randomized to
each consolidation arm.

To evaluate the association between total metabolic tumor volume (TMTV), SUV
max, and sum product (SPD) of diameters by PET-CT at first imaging response
with complete remission conversion up to one year in participants randomized to
each consolidation arm as well as those randomized to control.

To evaluate the overall response rate (ORR), CR rate, PFS, and OS of participants
randomized to Arm 4 (observation) who have lymphoma progression within 12
months of CAR T-cell infusion and subsequently ‘cross-over' to receive treatment
with mosunetuzumab + polatuzumab vedotin.

To estimate overall survival for all patients registered to this study.

To assess the difference in overall survival between participants who achieved CR
at first imaging (day +30) versus. those who did not achieve CR at first imaging.
Cancer Categories:
Hematologic (Blood Cancers)
Principal Investigator:
Uberti, Joseph
Karmanos Trial ID:
S2114
Age Group:
Adult
Phase:
Phase II
Learn More
A Randomized Phase III Study to Evaluate Benefits of Autologous Stem Cell Transplant in Patients with Peripheral T Cell Lymphoma that Achieved a First Complete Remission (CR1) Following Induction Therapy (PTCL-STAT)
Objective:

Primary Objective:

To demonstrate improvement in progression free survival (PFS) in the autologous stem cell transplant (ASCT) arm compared to the observation arm.

Secondary Objectives:

To assess difference in overall survival (OS) between the observation and autologous stem cell transplant (ASCT) arm.

To evaluate the differences in study intervention benefit for PFS and OS by the randomization stratification factors (histology and choice of induction chemotherapy).

To evaluate the cumulative incidence of relapse and mortality between the observational and autologous stem cell transplant (ASCT) arm.
Cancer Categories:
Hematologic (Blood Cancers)
Principal Investigator:
Modi, Dipenkumar
Karmanos Trial ID:
EA4232
Age Group:
Adult
Phase:
Phase III
Learn More

1 2 3 4 5 6 7