Alemtuzumab and Combination Chemotherapy in Treating Patients With Stage I, Stage II, Stage III, or Stage IV Peripheral T-Cell Lymphoma

NCT00562068 | Unknown Phase 1

• 7 other identifiers: CDR0000576439UCL-BRD/05/170EU-20785EUDRACT-2006-000365-11CTA 21786/0201/001-0001CRUK-UCL-BRD/05/170-CHOP-CAMPAUCL-CHOP-CAMPATH
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

Brief Summary

RATIONALE: Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from growing. Giving alemtuzumab together with combination chemotherapy may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of alemtuzumab when given together with combination chemotherapy and to see how well it works in treating patients with stage I , stage II , stage III, or stage IV peripheral T-cell lymphoma.

Conditions

Lymphoma; Small Intestine Cancer

Keywords

recurrent adult T-cell leukemia/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; anaplastic large cell lymphoma; angioimmunoblastic T-cell lymphoma; small intestine lymphoma; peripheral T-cell lymphoma

Outcome Measures

Primary Outcomes (3)

• Immediate toxicity (incidence of infusion-related reactions)

• Hematopoietic toxicity (number of cycles of therapy associated with neutrophils < 0.5e9/L or platelets < 50e9/L)

• Incidence of infection (number of days with fever ≥ 38 degrees C, days of intravenous antibiotics, number of inpatient days, number of episodes of cytomegalovirus reactivation)

Secondary Outcomes (6)

• Disease response (remission rate [complete response and partial response])

• Disease outcome (time to progression and overall survival at 2 years from completion of therapy)

• Immune reconstitution (time to recover peripheral blood CD4 count to 0.2 e9/L)

• Relative dose intensity

• Pharmacokinetics assessment of alemtuzumab trough levels before each cycle of treatment

Interventions

alemtuzumab BIOLOGICAL

cyclophosphamide DRUG

doxorubicin hydrochloride DRUG

prednisolone DRUG

vincristine sulfate DRUG

polymerase chain reaction GENETIC

flow cytometry OTHER

laboratory biomarker analysis OTHER

pharmacological study OTHER

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Diagnosis of peripheral T-cell lymphoma (PTCL), including the following subtypes: * PTCL not otherwise specified * Angioimmunoblastic T-cell lymphoma * Anaplastic lymphoma kinase-negative anaplastic large cell lymphoma * Intestinal T-cell lymphoma * Bulky stage IA and stages IB-IV disease (Ann Arbor staging system) * Expression of CD52 by the tumor * Measurable or evaluable disease * No anaplastic lymphoma kinase-positive anaplastic large-cell lymphoma * No CNS involvement with non-Hodgkin lymphoma PATIENT CHARACTERISTICS: * WHO performance status 0-2 * No presence of other serious, uncontrolled medical conditions * No significant anthracycline-related cardiac impairment * LVEF ≥ 50% * Creatinine ≤ 1.5 mg/dL * Bilirubin ≤ 2 times normal value unless due to disease * Not pregnant or nursing * Fertile patients must use effective barrier contraception during and for 1 month after completion of study treatment * No previous malignancy except adequately treated nonmelanoma skin cancer or cervical intraepithelial neoplasia * No positive serology or non-consenting to test for any of the following: * HIV * Hepatitis B or C * Human T-lymphotropic virus type 1 (HTLV-1) PRIOR CONCURRENT THERAPY: * No prior cytotoxic chemotherapy * Prior radiotherapy may be allowed at the trial coordinator's discretion * Concurrent consolidation radiotherapy may be given at the clinician's discretion

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 (5)

Leeds General Infirmary

Leeds, England, LS1 3EX, United Kingdom

RECRUITING

King's College Hospital

London, England, SE5 9RS, United Kingdom

RECRUITING

Royal Marsden - London

London, England, SW3 6JJ, United Kingdom

RECRUITING

Christie Hospital

Manchester, England, M20 4BX, United Kingdom

RECRUITING

Torbay Hospital

Torbay Devon, England, TQ2 7AA, United Kingdom

RECRUITING

Related Publications (1)

• Phillips EH, Devereux S, Radford J, Mir N, Adedayo T, Clifton-Hadley L, Johnson R. Toxicity and efficacy of alemtuzumab combined with CHOP for aggressive T-cell lymphoma: a phase 1 dose-escalation trial. Leuk Lymphoma. 2019 Sep;60(9):2291-2294. doi: 10.1080/10428194.2019.1576870. Epub 2019 Feb 18. No abstract available.

  PMID: 30773077 DERIVED

MeSH Terms

Conditions

Lymphoma; Precursor T-Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, Large-Cell, Anaplastic; Immunoblastic Lymphadenopathy; Lymphoma, T-Cell, Peripheral

Interventions

Alemtuzumab; Cyclophosphamide; Doxorubicin; Prednisolone; Vincristine; Polymerase Chain Reaction; Flow Cytometry

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; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphadenopathy

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Nucleic Acid Amplification Techniques; Genetic Techniques; Investigative Techniques; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical

Study Officials

• Roderick Johnson, MD

  Leeds General Infirmary

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 20, 2007
• First Posted: November 21, 2007
• Study Start: May 1, 2007
• Primary Completion: May 1, 2009
• Last Updated: August 26, 2013

Record last verified: 2008-11

Locations

GB (5)