LeukemiaPhase 1/2NCT00416351
Clofarabine in Treating Patients With T-Cell or Natural Killer-Cell Non-Hodgkin's Lymphoma That Has Relapsed or Not Responded to Previous Treatment
A Phase 1/2 study testing clofarabine in people with Leukemia and Lymphoma, run by Memorial Sloan Kettering Cancer Center at 3 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages 2 to 120 years
- Conditions the study is for
- Leukemia, Lymphoma, Small Intestine Cancer
- What is being tested?
- clofarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 3 sitesUnited States
- Study dates
- 27 Jun 2006to 1 Mar 2021
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed T-cell or natural killer (NK)-cell lymphoma, including any of the following subtypes:
- Blastic NK-cell lymphoma
- T/NK-cell lymphoma/leukemia
- Adult T-cell lymphoma/leukemia
- T-cell prolymphocytic leukemia
- T-lymphoblastic lymphoma
- Peripheral T-cell lymphoma, not otherwise specified
- Angioimmunoblastic T-cell lymphoma
- Anaplastic large cell lymphoma
- Transformed mycosis fungoides
- Subcutaneous panniculitis-like T-cell lymphoma
- Nasal T/NK-cell lymphoma
- Enteropathy-type T-cell lymphoma
- Hepatosplenic gamma/delta T-cell lymphoma
- Relapsed or refractory disease, meeting both of the following criteria:
- Must have been treated with prior cytotoxic chemotherapy and/or monoclonal antibody therapy
- No standard curative treatment exists
- Allogeneic bone marrow transplantation is not considered standard curative treatment
- Evaluable disease (Phase I)
- Measurable disease, defined as any nodal site or mass lesion ≥ 1.5 cm in longest transverse diameter on physical exam or CT scan OR a measurable extranodal site > 1 cm (Phase II)
- Patients with evaluable blood- or marrow-based disease are eligible
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Absolute neutrophil count ≥ 1,500/mm³ (Phase I)
- Absolute neutrophil count ≥ 500/mm³ (Phase II)
- Platelet count ≥ 100,000/mm³ (Phase I)
- Platelet count ≥ 50,000/mm³ (Phase II)
- Creatinine < 2.0 mg/dL*
- Bilirubin ≤ 2.0 times upper limit of normal (ULN)*
- AST and ALT ≤ 2.5 times ULN*
- No active infection requiring antibiotics
- No New York Heart Association class III or IV congestive heart failure
- No known HIV positivity
- No other active malignancy requiring therapy
- No other serious or life-threatening condition deemed unacceptable by the principal investigator
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception NOTE: *Unless due to lymphoma and patients are entering to the phase II portion of the study
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 3 weeks since prior therapy, including any of the following:
- Interferon
- Antibody therapy
- Retinoids
- Other non-chemotherapeutic treatment
- Concurrent stable-dose corticosteroids allowed
- No colony-stimulating factor therapy during the first course of study therapy
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: A Phase I/II Study of Clofarabine in Patients With Relapsed T-Cell and NK-Cell Lymphomas
RATIONALE: Drugs used in chemotherapy, such as clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I/II trial is studying the side effects and best dose of clofarabine and to see how well it works in treating patients with T-cell or natural killer-cell lymphoma that has relapsed or not responded to previous treatment.
Read the detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of clofarabine in patients with relapsed or refractory T-cell or natural killer-cell lymphoma.
- Determine the toxicity of this drug in these patients.
- Determine, preliminarily, the efficacy of this drug, in terms of response rate, in these patients.
OUTLINE: This is a phase I, non-randomized, dose-escalation study followed by an open-label, phase II study.
- Phase I: Patients receive clofarabine IV over 1 hour once daily on days 1-3. Treatment repeats every 21 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or partial response (PR) or complete response (CR) may receive 2 additional courses of treatment. Patients with PR or CR after completing 4 courses of therapy may receive 2 additional courses.
Cohorts of 1-6 patients receive escalating doses of clofarabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.
- Phase II: Patients receive clofarabine as in phase I at the MTD determined in phase I.
After completion of study treatment, patients are followed every 3 months for 2 years.
- Conditions
- Leukemia, Lymphoma, Small Intestine Cancer
- Being tested
- clofarabine
- Keywords
- anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent adult T-cell leukemia/lymphoma, recurrent mycosis fungoides/Sezary syndrome, adult nasal type extranodal NK/T-cell lymphoma, prolymphocytic leukemia, childhood nasal type extranodal NK/T-cell lymphoma, recurrent childhood lymphoblastic lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, small intestine lymphoma
- Medical subject headings
- Leukemia, Lymphoma, Lymphoma, Large-Cell, Anaplastic, Immunoblastic Lymphadenopathy, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Mycosis Fungoides, Sezary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clofarabineDrug
| Study group | Role | What they receive |
|---|---|---|
| Clofarabine | Experimental | Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels. Receives: Drug: clofarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose
Measured: 2 years
Response Rate for Participants With Non-Hodgkin's Lymphoma
Response rate as defined by complete remission, complete remission unconfirmed, partial remission, positron emission tomography (PET)-negative partial remission, stable disease, and progressive disease (Phase II)
Measured: 2 years
Secondary outcomes (1)
Participants Evaluated for Toxicity
Toxicity as defined by NCI Common Terminology Criteria for Adverse Events v 3.0
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2006 (estimated)
- Study start27 Jun 2006
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven M. Horwitz, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00416351
- Sponsor's protocol ID
- 06-065
- Other IDs
- P30CA008748, MSKCC-06065
- Status last verified
- Mar 2021
- First submitted
- 27 Dec 2006
- Last updated
- 17 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Clofarabine in Patients With Relapsed T-Cell and NK-Cell Lymphomas
- ClinicalTrials.gov ID
- NCT00416351
- Acronym / sponsor ID
- 06-065
- Conditions
- Leukemia, Lymphoma, Small Intestine Cancer
- Keywords
- anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent adult T-cell leukemia/lymphoma, recurrent mycosis fungoides/Sezary syndrome, adult nasal type extranodal NK/T-cell lymphoma, prolymphocytic leukemia, childhood nasal type extranodal NK/T-cell lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Rochester, The Cleveland Clinic
- Study start
- 27 Jun 2006 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 28 Dec 2006 (estimated)
- Results
- Posted 17 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I/II trial is studying the side effects and best dose of clofarabine and to see how well it works in treating patients with T-cell or natural killer-cell lymphoma that has relapsed or not responded to previous treatment.
Detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of clofarabine in patients with relapsed or refractory T-cell or natural killer-cell lymphoma.
- Determine the toxicity of this drug in these patients.
- Determine, preliminarily, the efficacy of this drug, in terms of response rate, in these patients.
OUTLINE: This is a phase I, non-randomized, dose-escalation study followed by an open-label, phase II study.
- Phase I: Patients receive clofarabine IV over 1 hour once daily on days 1-3. Treatment repeats every 21 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or partial response (PR) or complete response (CR) may receive 2 additional courses of treatment. Patients with PR or CR after completing 4 courses of therapy may receive 2 additional courses.
Cohorts of 1-6 patients receive escalating doses of clofarabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.
- Phase II: Patients receive clofarabine as in phase I at the MTD determined in phase I.
After completion of study treatment, patients are followed every 3 months for 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clofarabine | Experimental | Drug: clofarabinePatients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels. |
Who may qualify
- Ages
- 2 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| clofarabine | Drug | Clofarabine |
Primary outcome
Maximum Tolerated Dose
Time frame: 2 years
Response Rate for Participants With Non-Hodgkin's Lymphoma
Time frame: 2 years
Response rate as defined by complete remission, complete remission unconfirmed, partial remission, positron emission tomography (PET)-negative partial remission, stable disease, and progressive disease (Phase II)
1 secondary outcome
Participants Evaluated for Toxicity
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Steven M. Horwitz, MD principal investigator
Memorial Sloan Kettering Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing clofarabine in people with Leukemia and Lymphoma, run by Memorial Sloan Kettering Cancer Center at 3 sites 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?
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 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 17 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maximum Tolerated Dose (time frame: 2 years). The study lists 2 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 17 May 2022.