Mantle Cell LymphomaPhase 2NCT01148108
Study of Canfosfamide in Refractory or Relapsed Mantle Cell, Diffuse Large B Cell Lymphoma and Multiple Myeloma
A Phase 2 study testing Canfosfamide HCl for injection in people with Mantle Cell Lymphoma and B Cell Lymphoma, run by Telik at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mantle Cell Lymphoma, B Cell Lymphoma, Multiple Myeloma
- What is being tested?
- Canfosfamide HCl for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Sep 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
About this study
Official title: 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)
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.
- Conditions
- Mantle Cell Lymphoma, B Cell Lymphoma, Multiple Myeloma
- Being tested
- Canfosfamide HCl for injection
- Keywords
- 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
- Medical subject headings
- Lymphoma, Mantle-Cell, Lymphoma, B-Cell, Multiple Myeloma, Lymphoma, Non-Hodgkin, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Canfosfamide HCl for injectionDrug
Also called Telcyta, TLK286
30 min. intravenous infusion of canfosfamide HCl (1000 mg/m2) every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Mantle Cell Lymphoma | Experimental | Patients with relapsed or refractory mantle cell lymphoma Receives: Drug: Canfosfamide HCl for injection |
| Diffuse Large B Cell Lymphoma | Experimental | Patients with relapsed or refractory diffuse large B cell lymphoma Receives: Drug: Canfosfamide HCl for injection |
| Multiple Myeloma | Experimental | Patients with relapsed or refractory multiple myeloma Receives: Drug: Canfosfamide HCl for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 24 weeks of treatment
Secondary outcomes (2)
Duration of Response
Duration of response will be determined after disease progression is documented in patients who have an objective response.
Measured: 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.
Measured: At 3, 6, 9, & 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mantle Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Telik
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph Bertino, MD, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01148108
- Sponsor's protocol ID
- TLK286.2030
- Status last verified
- Mar 2013
- First submitted
- 17 Jun 2010
- Last updated
- 15 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT01148108
- Acronym / sponsor ID
- TLK286.2030
- Conditions
- Mantle Cell Lymphoma, B Cell Lymphoma, Multiple Myeloma
- Keywords
- NHL, Non-Hodgkins Lymphoma, Lymphoma, Mantle Cell, Diffuse Large B Cell, Multiple Myeloma, Telcyta, canfosfamide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- TelikIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 22 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mantle Cell Lymphoma | Experimental | Drug: Canfosfamide HCl for injectionPatients with relapsed or refractory mantle cell lymphoma |
| Diffuse Large B Cell Lymphoma | Experimental | Drug: Canfosfamide HCl for injectionPatients with relapsed or refractory diffuse large B cell lymphoma |
| Multiple Myeloma | Experimental | Drug: Canfosfamide HCl for injectionPatients with relapsed or refractory multiple myeloma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- relapsed or refractory disease
- histologically or cytologically confirmed disease
- characteristic immunophenotypic profiles
- measurable disease (for lymphoma patients)
- ECOG performance status of 0-2
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Canfosfamide HCl for injectionAlso: Telcyta, TLK28630 min. intravenous infusion of canfosfamide HCl (1000 mg/m2) every 2 weeks | Drug | Diffuse Large B Cell Lymphoma, Mantle Cell Lymphoma, Multiple Myeloma |
Primary outcome
Objective Response Rate
Time frame: At 6 weeks of treatment
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.
Objective Response Rate
Time frame: At 12 weeks of treatment
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.
Objective Response Rate
Time frame: At 18 weeks of treatment
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.
Objective Response Rate
Time frame: At 24 weeks of treatment
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.
2 secondary outcomes
Duration of Response
Time frame: At 6, 12, 18 & 24 weeks of treatment
Safety Assessments
Time frame: At 3, 6, 9, & 12 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Bertino, MD principal investigator
Rutgers Cancer Institute of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Canfosfamide HCl for injection in people with Mantle Cell Lymphoma and B Cell Lymphoma, run by Telik at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: At 6 weeks of treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2013; AzTrials last refreshed its copy on 27 Oct 2026.