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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)


Phase 2
18 Years
N/A
Not Enrolling
Both
Mantle Cell Lymphoma, B Cell Lymphoma, Multiple Myeloma

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Trial Information

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)


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response Rate

Outcome Description:

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.

Outcome Time Frame:

At 6 weeks of treatment

Safety Issue:

No

Principal Investigator

Joseph Bertino, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute of New Jersey

Authority:

United States: Food and Drug Administration

Study ID:

TLK286.2030

NCT ID:

NCT01148108

Start Date:

June 2010

Completion Date:

September 2012

Related Keywords:

  • Mantle Cell Lymphoma
  • B Cell Lymphoma
  • Multiple Myeloma
  • 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
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Mantle-Cell

Name

Location
Cancer Institute of New Jersey New Brunswick, New Jersey  08901