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 61

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 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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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 First in Human Study of the Menin-KMT2A (MLL1) Inhibitor JNJ-75276617 in Participants with Acute Leukemia
Objective:

Phase 1

Primary Objectives:

Part 1 (Dose Escalation): Determine the RP2D(s) of bleximenib

Part 2 (Dose Expansion): Determine safety and tolerability at the RP2D(s)

Secondary Objectives:

Assess pharmacokinetics

Assess preliminary clinical activity

Phase 2

Primary Objectives:

To evaluate the efficacy of bleximenib at the RP2D

Secondary Objectives:

To further assess the efficacy of bleximenib at the RP2D

To evaluate MRD rate at the RP2D

To assess the safety and tolerability of bleximenib at the RP2D

To assess the effect of bleximenib on transfusion requirements

To characterize PK of bleximenib at the RP2D

To assess PROs with bleximenib at the RP2D
Cancer Categories:
Hematologic (Blood Cancers)
Principal Investigator:
Yang, Jay
Karmanos Trial ID:
2024-077
Age Group:
Adult
Phase:
Phase I/II
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A Phase 1 First in Human Study of ARV-393 in Adult Participants with Advanced Non-Hodgkin's Lymphoma
Objective:

Primary Objectives:

To evaluate the safety and tolerability of ARV-393, determine MTD if necessary, and identify the RP2D(s) and dosing schedule

Secondary Objectives:

To characterize the pharmacokinetic profile of ARV-393 in plasma

To assess the preliminary anti-tumor activity of ARV-393
Cancer Categories:
Hematologic (Blood Cancers)
Principal Investigator:
Modi, Dipenkumar
Karmanos Trial ID:
2024-047
Age Group:
Adult
Phase:
Phase I
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A Phase 1/1b, Open-label, Multicenter, Dose Escalation and Dose Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of KQB198 as Monotherapy and in Combination with Anticancer Agents in Participants with Advanced Hematologic Malignancies
Objective:

Primary Objective:

Part 1: To determine the safety, tolerability, and RP2D of KQB198 as monotherapy and in combination with dasatinib

Part 2, Cohort A: To evaluate the efficacy of KQB198 in combination with dasatinib and determine the OBD

Part 2, Cohort B: To evaluate the efficacy of KQB198 monotherapy and determine the OBD

Secondary Objective:

Part 1: To evaluate the efficacy of KQB198 as monotherapy and in combination with dasatinib

Part 2, Cohorts A and B: To evaluate the efficacy of KQB198 monotherapy and in combination with dasatinib

All Parts: To evaluate the safety and tolerability of KQB198 as monotherapy and in combination with dasatinib

All Parts: To evaluate the plasma pharmacokinetics (PK) of KQB198 alone or KQB198 and dasatinib when administered in combination
Cancer Categories:
Hematologic (Blood Cancers)
Principal Investigator:
Yang, Jay
Karmanos Trial ID:
2024-055
Age Group:
Adult
Phase:
Phase I
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A Phase 1/2 Study of Linvoseltamab in Patients with Relapsed or Refractory Systemic Light Chain Amyloidosis
Objective:

Primary Objective:

Dose Escalation - Phase 1

To assess the safety, tolerability, and to determine the RP2DRs of linvoseltamab in participants with relapsed or refractory AL amyloidosis.

Dose Expansion - Phase 2 (Secondary for Phase 1)

To evaluate the effect of linvoseltamab on hematologic CR in participants with relapsed or refractory AL amyloidosis.

Secondary Objective: Phases 1 and 2

To evaluate the effect of linvoseltamab on hematologic VGPR or better response.

To evaluate the effect of linvoseltamab on overall hematologic response.

To evaluate the effect of linvoseltamab on the timing of hematologic Response.

To evaluate the effect of linvoseltamab on the duration of hematologic response.

To evaluate the effect of linvoseltamab on hematologic PFS.

To evaluate the safety of linvoseltamab.

Phase 2 only: To compare the efficacy between the 2 RP2DRs that are expected to be linvoseltamab 80 mg SC and 240 mg SC.

Phase 2 only: To compare the safety between the 2 RP2DRs that are expected to be linvoseltamab 80 mg SC and 240 mg SC.

To evaluate the impact of linvoseltamab on major organ deterioration and/or death.

To evaluate the impact of linvoseltamab on OS.

To evaluate the effect of linvoseltamab on induction of a clinically meaningful renal response in participants with baseline renal involvement.

To evaluate the effect of linvoseltamab on induction of a clinically meaningful cardiac response in participants with baseline cardiac involvement.

To evaluate the timing of renal response to linvoseltamab in participants with baseline renal involvement.

To evaluate the timing of cardiac response to linvoseltamab in participants with baseline cardiac involvement.

To evaluate the PK of linvoseltamab.

To assess the immunogenicity of linvoseltamab.
Cancer Categories:
Hematologic (Blood Cancers)
Principal Investigator:
Zonder, Jeffrey
Karmanos Trial ID:
2024-061
Age Group:
Adult
Phase:
Phase I/II
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A Phase 1b, Dose Escalation/Dose Expansion, Multicenter, Open-Label Study to Assess the Safety and Tolerability of OPN-6602 Monotherapy and in Combination with Dexamethasone in Subjects with Relapsed and/or Refractory Multiple Myeloma
Objective:

Primary Objective (Monotherapy Escalation):

To characterize the safety and tolerability of OPN-6602 in order to identify the RP2D

Secondary Objectives (Monotherapy Escalation):

To evaluate preliminary antitumor activity of OPN-6602

To evaluate the PK of OPN-6602

Primary Objective (Combination Escalation):

To characterize the safety and tolerability of OPN-6602 plus dexamethasone in order to identify the RP2D

Secondary Objectives (Combination Escalation):

To evaluate preliminary antitumor activity of OPN-6602 plus dexamethasone

To evaluate the PK of OPN-6602 when in combination with dexamethasone

Primary Objective (Expansion Monotherapy or Combination):

To evaluate preliminary antitumor activity of OPN-6602 when administered in combination with or without dexamethasone

Secondary Objectives (Expansion Monotherapy or Combination):

To further evaluate preliminary antitumor activity of OPN-6602 when administered in combination with or without dexamethasone

To evaluate the PK of OPN-6602 when administered in combination with or without Dexamethasone
Cancer Categories:
Hematologic (Blood Cancers)
Principal Investigator:
Zonder, Jeffrey
Karmanos Trial ID:
2024-056
Age Group:
Adult
Phase:
Phase I
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A Phase 2, Open-label, Single-arm, Multicohort, Multicenter Trial to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects with Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)
Objective:

Primary Objective:

The primary objective of the study is to evaluate the efficacy of JCAR017 in subjects with r/r follicular lymphoma and marginal zone lymphoma.

Secondary Objectives:

To evaluate other measures of efficacy

To evaluate the safety of JCAR017

To characterize the pharmacokinetic (PK) profile of JCAR017

To evaluate the Health-Related-Quality of Life (HRQoL) using preselected primary domains of interest in the EORTC QLQ-C30 (global health/QoL, physical functioning, cognitive functioning, fatigue, pain) and FACT-LymS (lymphoma specific symptoms)
Cancer Categories:
Hematologic (Blood Cancers)
Principal Investigator:
Modi, Dipenkumar
Karmanos Trial ID:
2024-086
Age Group:
Adult
Phase:
Phase II
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