Full Text View
Tabular View
No Study Results Posted
Related Studies
Safety and Efficacy of Campath in Nonmyeloablative Transplantation
This study is ongoing, but not recruiting participants.
First Received: June 5, 2002   Last Updated: February 16, 2009   History of Changes
Sponsored by: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00038844
  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

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma
Drug Information available for: Cyclophosphamide Fludarabine Fludarabine monophosphate Campath Rituximab Alemtuzumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Safety and Efficacy of Campath in Nonmyeloablative Transplantation

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

Primary Outcome Measures:
  • To see if low intensity chemotherapy given with the new drug Campath-1 H (alemtuzumab), followed by a transplant of blood or marrow stem cells from a donor, can increase the length of remission in patients with leukemia and lymphoma. [ Time Frame: 8 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: June 2001
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Campath-1 H + Fludarabine + Cyclophosphamide + rituximab
Drug: Campath-1 H (Alemtuzumab)
Starting Dose of 15 mg by vein daily, 3 days in a row.
Drug: Fludarabine
30 mg/m2 by vein daily, 3 days in a row.
Drug: Cyclophosphamide
1 gm/m2 by vein daily, 3 days in a row.
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.

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 HLA identical sibling is available. 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. PFT -OLCO<50%, cardiac EF <50% of predicted levels.
  7. Patient with severe concomitant medical or psychiatric illness.
  Contacts and Locations
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 U.T.M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: UT MD Anderson Cancer Center ( Issa F. Khouri, MD, BS/Professor )
Study ID Numbers: ID01-200
Study First Received: June 5, 2002
Last Updated: February 16, 2009
ClinicalTrials.gov Identifier: NCT00038844     History of Changes
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

Study placed in the following topic categories:
Antimetabolites
Immunoproliferative Disorders
Immunologic Factors
Rituximab
Cyclophosphamide
Fludarabine monophosphate
Immunosuppressive Agents
Leukemia
Lymphatic Diseases
Alemtuzumab
Antineoplastic Agents, Alkylating
Fludarabine
Lymphoproliferative Disorders
Antirheumatic Agents
Alkylating Agents
Lymphoma

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

ClinicalTrials.gov processed this record on May 07, 2009