High-Dose Chemotherapy Given Together With Peripheral Blood Stem Cell Transplant in Treating Patients With Intestinal T-Cell Lymphoma

NCT00669812 | Unknown Phase 2

• 3 other identifiers: CDR0000593564CRUK-2005-003906-27CRUK-BRD/05/93
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Giving chemotherapy before a peripheral blood stem cell transplant stops the growth of cancer cells by stopping them from dividing or by killing them. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. PURPOSE: This phase II trial is studying high-dose chemotherapy given together with peripheral blood stem cell transplant in treating patients with intestinal T-cell lymphoma.

Conditions

Lymphoma; Small Intestine Cancer

Keywords

small intestine lymphoma; stage I adult T-cell leukemia/lymphoma; stage II adult T-cell leukemia/lymphoma; stage III adult T-cell leukemia/lymphoma; stage IV adult T-cell leukemia/lymphoma

Outcome Measures

Primary Outcomes (1)

• Survival at 1 year

Secondary Outcomes (1)

• Toxicity

Interventions

carmustine DRUG

cyclophosphamide DRUG

cytarabine DRUG

doxorubicin hydrochloride DRUG

epirubicin hydrochloride DRUG

etoposide DRUG

ifosfamide DRUG

melphalan DRUG

methotrexate DRUG

prednisolone DRUG

vincristine sulfate DRUG

autologous hematopoietic stem cell transplantation PROCEDURE

biopsy PROCEDURE

peripheral blood stem cell transplantation PROCEDURE

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Newly confirmed diagnosis of intestinal T-cell lymphoma/ enteropathy-type T-cell lymphoma according to the following WHO classifications: * Usual phenotype CD3-, CD7-positive; CD5-, CD4-, CD8-negative; or CD30-positive * Complete surgical resection allowed PATIENT CHARACTERISTICS: * Unsupported neutrophils ≥ 1,500/mm\^3 unless attributed to lymphomatous bone marrow infiltration * Unsupported platelets ≥ 100,000/mm\^3 unless attributed to lymphomatous bone marrow infiltration * Creatinine clearance ≥ 50 mL/min * Alkaline phosphatase ≤ 2.5 times upper limit of normal (ULN) * Bilirubin ≤ 2.5 times ULN * Left ventricular ejection fraction ≥ 50% * Not pregnant or nursing * Fertile patients must use effective contraception during and for ≥ 1 month after completion of study treatment * Patients with any serious concomitant medical or psychiatric condition that would preclude them tolerating the planned treatment should be entered into the registration study only * No known hepatitis B, hepatitis C, or HIV positivity * No active uncontrolled cardiovascular disease * No abnormal EKG if there is a previous history of cardiac problems * No other severe impairment of cardiac function * No active malignancy within the past 5 years except cervical intraepithelial neoplasia or localized skin cancer PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Prior diagnostic or emergency surgical procedures allowed * More than 5 years since prior treatment for malignancy * No prior chemotherapy or radiotherapy for treatment of 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)

Sir James Spence Institute of Child Health at Royal Victoria Infirmary

Newcastle upon Tyne, England, NE1 4LP, United Kingdom

RECRUITING

Related Publications (1)

• Phillips EH, Lannon MM, Lopes A, Chadwick H, Jones G, Sieniawski M, Davies A, Wood K, Clifton-Hadley L, Smith P, Lawrie A, Chadwick N, Lennard AL. High-dose chemotherapy and autologous stem cell transplantation in enteropathy-associated and other aggressive T-cell lymphomas: a UK NCRI/Cancer Research UK Phase II Study. Bone Marrow Transplant. 2019 Mar;54(3):465-468. doi: 10.1038/s41409-018-0294-2. Epub 2018 Aug 13. No abstract available.

  PMID: 30104718 DERIVED

MeSH Terms

Conditions

Lymphoma; Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Carmustine; Cyclophosphamide; Cytarabine; Doxorubicin; Epirubicin; Etoposide; Ifosfamide; Melphalan; Methotrexate; Prednisolone; Vincristine; Biopsy; Peripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia; Hematologic Diseases

Intervention Hierarchy (Ancestors)

Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Oxazines; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation

Study Officials

• Anne Lennard

  Sir James Spence Institute of Child Health at Royal Victoria Infirmary

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 30, 2008
• First Posted: May 1, 2008
• Study Start: February 1, 2008
• Last Updated: August 26, 2013

Record last verified: 2008-11

Locations

GB (1)