Safety and Efficacy of Campath in Nonmyeloablative Transplantation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00038844
First received: June 5, 2002
Last updated: October 31, 2011
Last verified: October 2011
  Purpose

Objective of the low-dose transplant regimen must produce the following effects:

  1. Suppression of the patient's immune system to prevent rejection of the donor cells;
  2. Control of the lymphoma. The pretransplant regimen must suppress the lymphoma sufficiently to prevent marked progression of the tumor and allow time for the GVT effect to occur.

Condition Intervention
Lymphoma
Leukemia
Drug: Campath-1 H (Alemtuzumab)
Drug: Fludarabine
Drug: Cyclophosphamide
Drug: Rituximab

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Campath in Nonmyeloablative Transplantation

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Number of Participants Surviving 100 days post-transplant [ Time Frame: 30 Day Engraftment (Baseline) to 100 Days post-transplant ] [ Designated as safety issue: Yes ]

Enrollment: 65
Study Start Date: June 2001
Study Completion Date: September 2010
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Campath in Nonmyeloablative Transplantation
Campath-1 H Starting Dose of 15 mg by vein daily, 3 days in a row + Fludarabine 30 mg/m2 by vein daily, 3 days in a row + Cyclophosphamide 1 gm/m2 by vein daily, 3 days in a row + Rituximab 375 mg/m2 by vein, given 8 days before transplant then weekly for 4 total doses.
Drug: Campath-1 H (Alemtuzumab)
Starting Dose of 15 mg by vein daily, 3 days in a row.
Other Names:
  • Campath
  • Alemtuzumab
Drug: Fludarabine
30 mg/m2 by vein daily, 3 days in a row.
Other Names:
  • Fludarabine Phospate
  • Fludara
Drug: Cyclophosphamide
1 gm/m2 by vein daily, 3 days in a row.
Other Names:
  • Cytoxan
  • Neosar
Drug: Rituximab
375 mg/m2 by vein, given (to some patients only, based on the subtypes of lymphomas) eight days before the transplant and then weekly for a total of 4 doses.
Other Name: Rituxan

Detailed Description:

Alemtuzumab is a drug that can specifically attack some types of leukemia and lymphoma cells. In addition, it suppresses the patients' immune system, therefore helps preventing the rejection of donor marrow or stem cells.

Before treatment starts, patients will have a physical exam, including blood tests (between 100 - 120 cc) and urine tests. Women who are able to have children will have a pregnancy test. Bone marrow samples will be taken. Patients will have a chest x-ray, CT scans and EKG, and tests of lung function.

Blood tests (between 100 - 120 cc) marrow sampling, and x-rays will be done as needed to track the effects of the transplant. For bone marrow sampling, a large needle is placed into the numbed hipbone. The bone marrow is then withdrawn through the needle. Patients will have transfusions of blood and platelets as needed. Blood tests (between 100 - 120 cc) will be done daily while patients are in the hospital.

Alemtuzumab will be injected into the patient's vein. This will be done 3 days in a row (days 1 to 3). The drugs diphenhydramine (Benadryl) and acetaminophen (Tylenol) will be given in to prevent or ease side effects.

Patients will also receive fludarabine and cyclophosphamide daily for 3 days. They will be given on the same days as alemtuzumab. Rituximab will be given (to some patients only, based on the subtypes of lymphomas) eight days before the transplant and then weekly for a total of 4 doses.

All of the chemotherapy drugs will be given through a catheter (plastic tube) that extends into the large chest vein. The catheter will be left in place throughout treatment. When chemotherapy is finished, blood stem cells from a donor will be given through the catheter. G-CSF, a growth factor that promotes the production of blood cells, will be injected under the skin once a day until the neutrophil counts recover in the blood.

A "boost" of donor cells (lymphocytes) will be given at 3 months after transplant if the disease is getting worse or if DNA tests from the blood shows that not all lymphocytes in the blood are from the donor. These cells will be given through the vein, without chemotherapy, in the clinic.

Treatment will be given in the hospital at M. D. Anderson. Patients will need to stay in the hospital for about 3 to 4 weeks. Patients will be taken off study if their disease progresses.

Patients must stay in the Houston area for about 100 days after the transplant. After that, patients will need to return to Houston from time to time for blood tests, urine tests, and other exams.

This is an investigational study. The FDA has approved the drugs used in this study. Their use together in this study is investigational. About 100 patients will take part in this study. All will be enrolled at M. D. Anderson.

  Eligibility

Ages Eligible for Study:   up to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Up to 70 years of age (physiological).
  2. Any histological subtype of lymphoid malignancies (those with CD20 negative disease will not receive Rituximab).
  3. Patients in relapse with a partial remission or stable disease.
  4. Patients who failed a prior autologous transplant are also eligible.
  5. Patients must have a matched unrelated donor and no human leukocyte antigen (HLA) identical sibling is available. Point scale (PS)<2.
  6. Patients are included even if they were previously exposed to Campath or Rituximab.

Exclusion Criteria:

  1. Past history of anaphylaxis following exposure to rat- or mouse-derived COR-grafted humanized monoclonal antibodies.
  2. Less than 4 weeks since prior chemotherapy counted from 1st day of treatment regimen.
  3. Pregnancy or lactation.
  4. HIV or HTLV-I positively.
  5. Serum creatinine >1.6mg/dl or serum bilirubin >1.5mg/dl unless due to tumor.
  6. Pulmonary function tests (PFTs) -OLCO<50%, cardiac EF <50% of predicted levels.
  7. Patient with severe concomitant medical or psychiatric illness.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038844

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Issa F. Khouri, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00038844     History of Changes
Other Study ID Numbers: ID01-200
Study First Received: June 5, 2002
Last Updated: October 31, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Lymphoma
Leukemia
Campath-1 H
Campath
Alemtuzumab
Fludarabine
Fludarabine Phosphate
Fludara
Cyclophosphamide
Cytoxan
Neosar
Rituxan
Rituximab

Additional relevant MeSH terms:
Leukemia
Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Alemtuzumab
Cyclophosphamide
Fludarabine
Fludarabine phosphate
Rituximab
Alkylating Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014