Fludarabine, Cyclophosphamide, and Thalidomide in Treating Patients With Angioimmunoblastic T-Cell Lymphoma

NCT00958854 | Unknown Phase 2

• 4 other identifiers: CDR0000644123CRUK-UCL-AITLEUDRACT-2005-003931-40EU-20947
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Thalidomide may stop the growth of lymphoma by blocking blood flow to the cancer. Giving fludarabine and cyclophosphamide together with thalidomide may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving fludarabine and cyclophosphamide together with thalidomide works in treating patients with angioimmunoblastic T-cell lymphoma.

Conditions

Lymphoma

Keywords

angioimmunoblastic T-cell lymphoma

Outcome Measures

Primary Outcomes (1)

• Response rate after chemotherapy with fludarabine and cyclophosphamide

Secondary Outcomes (3)

• Incremental response rate to thalidomide treatment

• Toxicity according to the NCI CTCAE v.3.0

• Progression-free and overall survival

Interventions

cyclophosphamide DRUG

fludarabine phosphate DRUG

thalidomide DRUG

laboratory biomarker analysis OTHER

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Newly diagnosed angioimmunoblastic T-cell lymphoma * Measurable disease (i.e., anatomically assessable) PATIENT CHARACTERISTICS: * WHO/ECOG performance status 0-2 * Serum creatinine ≤ 2.5 times upper limit of normal (ULN) * Bilirubin ≤ 2.5 times ULN * Alkaline phosphatase ≤ 2.5 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception before, during, and after study treatment * No known seropositivity for hepatitis B virus, hepatitis C virus, or HIV * No active second malignancy or other concomitant serious medical condition, in particular peripheral neuropathy PRIOR CONCURRENT THERAPY: * No prior chemotherapy for angioimmunoblastic T-cell lymphoma

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Cancer Research UK: lead

Study Sites (1)

Cancer Research UK and University College London Cancer Trials Centre

Exeter, England, EX2 5DW, United Kingdom

RECRUITING

MeSH Terms

Conditions

Lymphoma; Immunoblastic Lymphadenopathy

Interventions

Cyclophosphamide; fludarabine phosphate; Thalidomide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphadenopathy

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Claudius Rudin, MD

  Royal Devon and Exeter Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 12, 2009
• First Posted: August 13, 2009
• Study Start: January 1, 2006
• Primary Completion: March 1, 2012
• Last Updated: August 26, 2013

Record last verified: 2009-08

Locations

GB (1)