Carmustine, Etoposide, Cytarabine, Melphalan, and Alemtuzumab Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma

NCT00908180 | Unknown Phase 2

• 5 other identifiers: CRUK-PAIReDCDR0000640493EUDRACT-2008-004956-60EU-20930UCL/08/0121
• Study Type: interventional
• Target: 47
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. Monoclonal antibodies, such as alemtuzumab, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine before and after the transplant may stop this from happening. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer cells as not belonging in the patient's body and destroy them (called graft-versus-tumor effect). Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) may boost this effect. PURPOSE: This phase II trial is studying the side effects of giving carmustine together with etoposide, cytarabine, melphalan, and alemtuzumab followed by donor stem cell transplant and to see how well it works in treating patients with relapsed or refractory Hodgkin lymphoma.

Conditions

Lymphoma

Keywords

recurrent adult Hodgkin lymphoma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival at 3 years

Secondary Outcomes (8)

• Donor engraftment rates, including chimerism at 3 and 6 months

• Non-relapse mortality at 100 days, 1 year, and 2 years post-transplant

• Incidence of grade II-IV toxicity as assessed by NCI CTCAE v3.0

• Incidence, severity, and timing of acute and chronic graft-versus-host disease

• Response rates

Interventions

alemtuzumab BIOLOGICAL

donor lymphocytes BIOLOGICAL

carmustine DRUG

cyclosporine DRUG

cytarabine DRUG

etoposide DRUG

melphalan DRUG

allogeneic hematopoietic stem cell transplantation PROCEDURE

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Confirmed diagnosis of Hodgkin lymphoma, meeting 1 of the following criteria: * Refractory to initial multi-agent induction therapy and achieved less than a complete response to one line of salvage chemotherapy * In first relapse and achieved less than a partial response to one line of salvage chemotherapy * No progressive disease * Must have an HLA-matched (≥ 9/10) sibling or unrelated donor available PATIENT CHARACTERISTICS: * WHO performance status 0-1 * Creatinine clearance ≥ 50 mL/min * Serum bilirubin ≤ 1.5 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 2 times ULN * LVEF ≥ 40% * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 2-3 months after completion of study treatment * No HIV positivity * No other malignancy within the past 5 years, except for nonmelanoma skin cancer or stage 0 (in situ) cervical carcinoma * No concurrent serious medical condition that would preclude an allograft * No symptomatic respiratory compromise PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior high-dose therapy or allograft

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

Related Publications (1)

• Das-Gupta E, Thomson KJ, Bloor AJC, Clark AD, Mackinnon S, Kayani I, Clifton-Hadley L, Patrick P, El-Mehidi N, Lawrie A, Kirkwood AA, Russell NH, Linch DC, Peggs KS. Allo-HSCT in transplant-naive patients with Hodgkin lymphoma: a single-arm, multicenter study. Blood Adv. 2019 Dec 23;3(24):4264-4270. doi: 10.1182/bloodadvances.2019001016.

  PMID: 31869413 DERIVED

MeSH Terms

Conditions

Lymphoma; Hodgkin Disease

Interventions

Alemtuzumab; Carmustine; Cyclosporine; Cytarabine; Etoposide; Melphalan

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Glucosides; Glycosides; Carbohydrates; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids

Study Officials

• Karl Peggs, MD

  University College London (UCL) Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 22, 2009
• First Posted: May 25, 2009
• Study Start: July 1, 2009
• Primary Completion: July 1, 2014
• Last Updated: August 2, 2013

Record last verified: 2009-06