Oral Clofarabine for Relapsed/Refractory Non-Hodgkin Lymphoma

NCT00644189 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: 07-401
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

Oral clofarabine is related to two intravenous chemotherapy drugs used for this disease and works in two different ways. It affects the development of new cancer cells by blocking two enzymes that cancer cells need to reproduce. When these enzymes are blocked, the cancer call can no longer prepare the DNA needed to make new cells. Clofarabine also encourages existing cancer cells to die by disturbing components within the cancer cell. This causes the release of a substance that is fatal to the cell. This trial studies the efficacy of oral clofarabine in the treatment of relapsed non-Hodgkin lymphomas.

Conditions

Follicular Lymphoma; Marginal Zone Lymphoma; Mantle Cell Lymphoma; Small Lymphocytic Lymphoma; Lymphoplasmacytic Lymphoma; Low Grade B-cell Lymphoma, Not Otherwise Specified; Diffuse Large B-cell Lymphoma; Peripheral T-cell Lymphoma; Angioimmunoblastic T-cell Lymphoma; Anaplastic Large-cell Lymphoma

Keywords

clofarabine; Clolar; lymphoma; NHL; oral chemotherapy

Outcome Measures

Primary Outcomes (2)

• All Phase I-II Participants: Overall Response Rate (ORR)

  Determine the efficacy of oral clofarabine (any of the 4 dose levels: 1mg, 2mg, 4mg, and 3mg) in all phase I-II trial patients with relapsed/refractory non-Hodgkin lymphomas. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

  after at most 6 28-day cycles

• Phase I Participants Only: Overall Response Rate (ORR)

  Determine the efficacy of oral clofarabine (any of the 4 dose levels: 1mg, 2mg, 4mg, and 3mg) in all phase I trial patients with relapsed/refractory non-Hodgkin lymphomas. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

  after at most 6 28-day cycles

Secondary Outcomes (8)

• Phase I-II Participants Treated at the RP2D (3mg): Overall Response Rate (ORR)

  after at most 6 28-day cycles

• All Phase I-II Participants: Progression-free Survival (PFS)

  at 1 and 2 years

• All Phase I-II Participants: Overall Survival (OS)

  3 years

• All Phase I-II Participants: Safety

  during 6 28-day cycles and 90 days out

• Phase I Participants Treated at the RP2D (3mg): Overall Response Rate (ORR)

  after at most 6 28-day cycles

Study Arms (1)

Clofarabine

OTHER

Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.

Drug: Clofarabine

Interventions

Clofarabine DRUG

Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.

Also known as: Clolar

Clofarabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed relapsed or refractory NHL that includes: follicular lymphoma of any grade; marginal zone lymphoma; small lymphocytic lymphoma/chronic lymphocytic leukemia; mantle cell lymphoma; lymphoplasmacytic lymphoma; low-grade B-cell lymphoma not otherwise specified; diffuse large B-cell lymphoma, anaplastic large cell lymphoma, peripheral T-cell lymphoma, angioimmunoblastic T-cell lymphoma.
• One or more prior line of chemotherapy, immunotherapy, or radioimmunotherapy.
• Measurable disease on cross sectional imaging of at least 2cm.
• ECOG Performance Status 0-2
• years of age or older
• Life expectancy of greater than 3 months
• Normal organ and marrow function as outlined in the protocol
• Must agree to use adequate contraception prior to study entry and for the duration of study participation

You may not qualify if:

• Patients who have had chemotherapy, rituximab, or radiotherapy within 4 weeks, or radioimmunotherapy within 8 weeks prior to entering the study
• Receiving any other investigational agent
• Known brain metastases
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to Clofarabine
• Systemic fungal, bacterial, viral, or other infection not controlled
• Pregnant or lactating
• Prior history of another malignancy (except for non-melanoma skin cancer or in situ cervical or breast cancer) unless disease free for over one year
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Prior allogeneic stem cell transplantation

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Dana-Farber Cancer Institute: collaborator
• Brigham and Women's Hospital: collaborator
• Genzyme, a Sanofi Company: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Lymphoma, Follicular; Lymphoma, B-Cell, Marginal Zone; Lymphoma, Mantle-Cell; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Large B-Cell, Diffuse; Lymphoma, T-Cell, Peripheral; Immunoblastic Lymphadenopathy; Lymphoma, Large-Cell, Anaplastic; Lymphoma

Interventions

Clofarabine

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, T-Cell; Lymphadenopathy

Intervention Hierarchy (Ancestors)

Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Nucleotides; Ribonucleotides

Results Point of Contact

• Title: Jeremy Abramson, MD
• Organization: Massachusetts General Hospital Cancer Center

jabramson@mgh.harvard.edu

617-724-4000

Study Officials

• Jeremy Abramson, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Lymphoma Program

Study Record Dates

• First Submitted: March 24, 2008
• First Posted: March 26, 2008
• Study Start: June 1, 2008
• Primary Completion: December 1, 2013
• Study Completion: July 1, 2021
• Last Updated: March 15, 2023
• Results First Posted: May 8, 2017

Record last verified: 2023-03

Locations

US (2)