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.

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Results 1 - 10 of 51

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
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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
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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
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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
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Master Screening and Reassessment Protocol (MSRP) for the NCI MyeloMATCH Clinical Trials
Objective:

Primary Objectives:

Screening and Reassessment (MSRP): To evaluate the feasibility of MATCHBox receiving and organizing all data needed for assignment to a myeloMATCH clinica >trial or Tier Advancement Pathway (TAP) within 72 hours of MDNet receipt of al >required specimens for initial therapy and within 10 days for subsequent therapy.

Tier Advancement Pathway (TAP): To enable participants who are not matched to an investigational myeloMATCH treatment substudy to receive standard of care (SOC) while remaining on the MSRP to maintain access to later tiers of treatment substudies.

Secondary Objectives:

Screening and Reassessment (MSRP)

To describe the time to generation of all data required for treatment substudy (or TAP) assignment, time to treatment substudy (or TAP) assignment, percent assigned to a myeloMATCH treatment substudy, and the percent of screened participants who register to a myeloMATCH investigational treatment substudy or are assigned to TAP:

Separately within each tier of myeloMATCH treatment substudy and analogous TAP assignment (see Section 2.1 for tier definitions)

Separately within each clinical basket of myeloMATCH treatment substudies (see Section 2.2 for clinical basket definitions).

Over time, across and within the categories above.

Tier Advancement Pathway (TAP)

To evaluate participants for assignment to higher tier treatment substudies within myeloMATCH.

To describe, within tier- and basket- levels of TAP, measurable residual disease (MRD) rates and clonal evolution.

To describe, within tier- and basket- levels of TAP, remission status and overall survival of participants who receive standard of care therapy.

To obtain MDNet specimens for translational medicine and biobanking.
Cancer Categories:
Hematologic (Blood Cancers)
Principal Investigator:
Singh, Vijendra
Karmanos Trial ID:
MYELOMATCH
Age Group:
Adult
Phase:
N/A
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Randomized Phase III Study of Mosunetuzumab vs. Rituximab for Low Tumor Burden Follicular Lymphoma
Objective:

Co-Primary Objectives:

To compare the 3-year milestone progression free survival (PFS) probabilities in participants with previously untreated, low tumor burden follicular lymphoma randomized to the rituximab arm versus the mosunetuzumab arm.

To compare progression free survival (PFS) in participants with previously untreated, low tumor burden follicular lymphoma randomized to the rituximab arm versus the mosunetuzumab arm.

Secondary Objectives:

To compare overall survival (OS) between participants randomized to rituximab versus mosunetuzumab.

To compare overall response rates at the Week 40 assessment between participants randomized to rituximab versus mosunetuzumab.

To compare event free survival (EFS) between participants randomized to rituximab versus mosunetuzumab.

To compare the frequency and severity of toxicities between participants randomized to rituximab versus mosunetuzumab.

To compare the restricted chance of longer PFS (2-6 years) between participants randomized to rituximab versus mosunetuzumab.
Cancer Categories:
Hematologic (Blood Cancers)
Principal Investigator:
Modi, Dipenkumar
Karmanos Trial ID:
S2308
Age Group:
Adult
Phase:
Phase III
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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
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A Phase 1b/2 Study of AZD0120 (also known as GC012F), a Chimeric Antigen Receptor T-cell (CAR-T) Therapy Targeting CD19 and B-cell Maturation Antigen (BCMA) in Participants with Relapsed or Refractory AL Amyloidosis
Objective:

Phase 1b

Primary Objectives:

To evaluate the safety and tolerability of AZD0120, and determine the RP2D of AZD0120 in participants with AL amyloidosis

Secondary Objectives:

To evaluate the efficacy of AZD0120 in participants with AL amyloidosis

To characterize the CK of AZD0120 in peripheral blood following a single-dose of AZD0120 in participants with AL amyloidosis

To assess immunogenicity of AZD0120 in participants with AL amyloidosis

Phase 2

Primary Objectives:

To evaluate the efficacy of AZD0120 in participants with AL amyloidosis

Secondary Objectives:

To further evaluate the efficacy of AZD0120 in participants with AL amyloidosis

To characterize the safety of AZD0120 in participants with AL amyloidosis

To characterize the CK of AZD0120 in peripheral blood following a single-dose of AZD0120 in participants with AL amyloidosis

To assess immunogenicity of AZD0120 in participants with AL amyloidosis

To assess the effect of AZD0120 on overall health status in participants with AL amyloidosis
Cancer Categories:
Hematologic (Blood Cancers)
Principal Investigator:
Zonder, Jeffrey
Karmanos Trial ID:
2025-042
Age Group:
Adult
Phase:
Phase I/II
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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
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A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients with Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation
Objective:

COMMON OBJECTIVES ACROSS PLATFORM PROTOCOL

To assess GRFS post HCT

To assess GVHD-free survival (GFS) post HCT

To assess infection-free survival (IFS) post HCT

To assess overall survival post HCT

To assess progression-free survival (PFS) post HCT

To assess NRM post HCT

To assess the cumulative incidence of relapse and disease progression post HCT

To assess the cumulative incidence of neutrophil engraftment post HCT

To assess the cumulative incidence of platelet engraftment post HCT

To assess primary graft failure and secondary graft failure post HCT

To assess the incidence of ≥ Grade 2 infections post HCT

To assess donor cell engraftment post HCT

To assess the cumulative incidence of aGVHD post HCT

To assess the cumulative incidence of cGVHD post HCT

To assess the incidence of cytokine release syndrome (CRS) post HCT

COMMON SAFETY OBJECTIVES ACROSS PLATFORM PROTOCOL

To assess serious adverse events from the start of conditioning regimen through 1 year post HCT

To assess all adverse events (AEs) Grade 3 and higher from initiation of conditioning regimen through 1 year post HCT based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0

To assess adverse events of special interest (if applicable in each ISA)
Cancer Categories:
Hematologic (Blood Cancers)
Principal Investigator:
Modi, Dipenkumar
Karmanos Trial ID:
2025-013
Age Group:
Adult
Phase:
Phase II
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