Study of Canfosfamide in Refractory or Relapsed Mantle Cell, Diffuse Large B Cell Lymphoma and Multiple Myeloma

Study Overview
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Brief Summary
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This is a Phase 2 study to determine the efficacy and safety of canfosfamide treatment in relapsed or refractory mantle cell lymphoma, diffuse large B cell lymphoma and multiple myeloma. The study will be conducted in two stages with 5-6 patients in each indication in Stage 1 and if responses are observed an additional 10 patients in Stage 2 in each group.

Official Title
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Phase 2 Study of Canfosfamide HCl for Injection (Telcyta®, TLK286)in Refractory or Relapsed Mantle Cell Lymphoma (MCL), Diffuse Large B Cell Lymphoma (DLBCL) and Multiple Myeloma (MM)

Conditions
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Mantle Cell Lymphoma, B Cell Lymphoma, Multiple Myeloma

Intervention / Treatment
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* Drug: Canfosfamide HCl for injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: relapsed or refractory disease histologically or cytologically confirmed disease characteristic immunophenotypic profiles measurable disease (for lymphoma patients) ECOG performance status of 0-2 adequate liver and kidney function adequate bone marrow reserves ineligible or unwilling to undergo autologous stem cell transplantation Exclusion Criteria: failure to recover from any major surgery within 4 weeks of study entry pregnant or lactating women women of child-bearing potential not using reliable and appropriate contraception routine prophylactic use of G-CSF required within 2 weeks of study entry Grade 3 or higher peripheral neuropathy history of hepatitis B virus or HIV central nervous system or meningeal involvement by lymphoma or multiple myeloma

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mantle Cell Lymphoma<br>Patients with relapsed or refractory mantle cell lymphoma | Drug: Canfosfamide HCl for injection<br>* 30 min. intravenous infusion of canfosfamide HCl (1000 mg/m2) every 2 weeks<br>* Other names: TLK286;|
| Experimental: Diffuse Large B Cell Lymphoma<br>Patients with relapsed or refractory diffuse large B cell lymphoma | Drug: Canfosfamide HCl for injection<br>* 30 min. intravenous infusion of canfosfamide HCl (1000 mg/m2) every 2 weeks<br>* Other names: TLK286;|
| Experimental: Multiple Myeloma<br>Patients with relapsed or refractory multiple myeloma | Drug: Canfosfamide HCl for injection<br>* 30 min. intravenous infusion of canfosfamide HCl (1000 mg/m2) every 2 weeks<br>* Other names: TLK286;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate | Disease will be assessed every 6 weeks using International Working Group Response Criteria for Non-Hodgkins Lymphoma in the mantle cell and diffuse large B cell lymphoma patients and the International Myeloma Working Group Response Criteria for multiple myeloma patients. Patients will continue to be treated and disease assessed until disease progression or unacceptable toxicity. | At 6 weeks of treatment | 
| Objective Response Rate | Disease will be assessed every 6 weeks using International Working Group Response Criteria for Non-Hodgkins Lymphoma in the mantle cell and diffuse large B cell lymphoma patients and the International Myeloma Working Group Response Criteria for multiple myeloma patients. Patients will continue to be treated and disease assessed until disease progression or unacceptable toxicity. | At 12 weeks of treatment | 
| Objective Response Rate | Disease will be assessed every 6 weeks using International Working Group Response Criteria for Non-Hodgkins Lymphoma in the mantle cell and diffuse large B cell lymphoma patients and the International Myeloma Working Group Response Criteria for multiple myeloma patients. Patients will continue to be treated and disease assessed until disease progression or unacceptable toxicity. | At 18 weeks of treatment | 
| Objective Response Rate | Disease will be assessed every 6 weeks using International Working Group Response Criteria for Non-Hodgkins Lymphoma in the mantle cell and diffuse large B cell lymphoma patients and the International Myeloma Working Group Response Criteria for multiple myeloma patients. Patients will continue to be treated and disease assessed until disease progression or unacceptable toxicity. | At 24 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Response | Duration of response will be determined after disease progression is documented in patients who have an objective response. | At 6, 12, 18 & 24 weeks of treatment | 
| Safety Assessments | Toxicity will be assessed throughout study using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0. | At 3, 6, 9, & 12 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NHL, Non-Hodgkins Lymphoma, Lymphoma, Mantle Cell, Diffuse Large B Cell, Multiple Myeloma, Telcyta, canfosfamide, TLK286, Prodrug, Enzyme activated drug, Glutathione Transferase P1-1 activated drug, GSTp1-1 activated drug, Glutathione Transferase activated drug, Glutathione, Glutathione analong