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

Telik

Status and phase: Completed; Phase 2

Conditions: Multiple Myeloma; B Cell Lymphoma; Mantle Cell Lymphoma

Treatments: Drug: Canfosfamide HCl for injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT01148108

TLK286.2030

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

14 participants in 3 patient groups

Mantle Cell Lymphoma

Experimental group

Description:

Patients with relapsed or refractory mantle cell lymphoma

Treatment:

Drug: Canfosfamide HCl for injection

Diffuse Large B Cell Lymphoma

Experimental group

Description:

Patients with relapsed or refractory diffuse large B cell lymphoma

Treatment:

Drug: Canfosfamide HCl for injection

Multiple Myeloma

Experimental group

Description:

Patients with relapsed or refractory multiple myeloma

Treatment:

Drug: Canfosfamide HCl for injection