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Campath-1H and Allogeneic Blood Stem Cell Transplantation for Lymphoid Malignancies

Primary Purpose

Leukemia, Lymphocytic, Chronic, Leukemia, Lymphocytic, Acute, Lymphoma, Low-Grade

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Campath-1H
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia, Lymphocytic, Chronic focused on measuring Lymphoid Malignancies, Chronic Lymphocytic Leukemia, Acute Lymphoblastic Leukemia, Low grade Lymphoma, B and T cell Lymphoma of the intermediate and high grade

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 15-65 years old B or T-cell lymphoid disease, not eligible for non-myeloablative transplantation. Patients in relapse after failing conventional chemotherapy. Patients with HLA-identical or one-antigen mismatched sibling, or a matched unrelated donor. Performance status </=2. Exclusion Criteria: Past history of anaphylaxis following exposure to rat or mouse derived CDR-grafted humanized monoclonal antibodies. Less than 4 weeks since prior chemotherapy. Pregnancy or lactation. HIV or HTLV-I positivity. Serum creatinine >1.6 mg/dl or serum bilirubin >0.2 mg/dl unless due to tumor, SGPT >/= 2 x NI PFT-DCLO<50%, cardiac EF <50% of predicted levels.

Sites / Locations

  • UT MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Campath-1H

Arm Description

10 mg/day x 5

Outcomes

Primary Outcome Measures

CAMPATH 2-year event-free survival rate

Secondary Outcome Measures

Full Information

First Posted
June 5, 2002
Last Updated
November 6, 2018
Sponsor
M.D. Anderson Cancer Center
Collaborators
Leudosite
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1. Study Identification

Unique Protocol Identification Number
NCT00038883
Brief Title
Campath-1H and Allogeneic Blood Stem Cell Transplantation for Lymphoid Malignancies
Official Title
Campath-1H Snd Allogeneic Blood Stem Cell Transplantation for Lymphoid Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Terminated
Study Start Date
April 9, 2001 (Actual)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
Leudosite

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
High dose chemotherapy followed by transplantation of allogeneic hematopoietic stem cell with the use of Campath-1h, a monoclonal antibody that have a synergistic effect to chemotherapy with minimal toxicity. In addition Campath-1H can improve engraftment of donor cells through its immunosuppressive properties.
Detailed Description
Alemtuzumab is a drug that is designed to specifically attack some types of leukemia and lymphoma cells. In addition, it weakens the immune system, helping to prevent the rejection of donor marrow or stem cells. If you are found to be eligible to take part in this study, you will be admitted to the hospital for treatment. Alemtuzumab will be injected into your vein over a period of 4 hours. This will be done 5 days in a row (Days 1 to 5). Drugs diphenhydramine (Benadryl), solumedrol and acetaminophen (Tylenol) will be given in to decrease the risk of or ease side effects before each dose of the alemtuzumab. You will also receive Carmustine over one hour on the first day. From the second to the fifth day, you will receive cytarabine and etoposide twice a day. On the six day, you will receive melphalan once. Both 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 on this study. Some participants, depending on their type of disease, will also receive rituximab. Rituximab will be given during the first day of chemotherapy then once a week for a total of 4 doses. 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 your blood cell counts recover to a certain level. Blood tests (about 2 tablespoons each) , urine tests, bone marrow aspirations, and x-rays will be done as needed to track the effects of the transplant. The blood tests will be drawn daily while in the hospital and then at least twice weekly as an outpatient for the first 100 days. The CT scans and bone marrow studies will be done at 1, 3, 6, and 12 months and then every 6 months for at least 3 years after transplant. You may also have transfusions of blood and platelets as needed. You will need to stay in the hospital about 3 to 4 weeks. You will be taken off study if their disease gets worse or intolerable side effects occur. You must stay in the Houston area for about 100 days after the transplant. After that, you will be asked to return to Houston every 6 months for the next 3-5 years for scans (CT, gallium, or PET scans), and bone marrow aspirations over the next 3-5 years. This is an investigational study. The FDA has approved the drugs used in this study. Their use together in this study is investigational. About 142 patients will take part in this study. All will be enrolled at M. D. Anderson.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphocytic, Chronic, Leukemia, Lymphocytic, Acute, Lymphoma, Low-Grade, Lymphoma, T-Cell, Lymphoma, B-Cell
Keywords
Lymphoid Malignancies, Chronic Lymphocytic Leukemia, Acute Lymphoblastic Leukemia, Low grade Lymphoma, B and T cell Lymphoma of the intermediate and high grade

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Campath-1H
Arm Type
Experimental
Arm Description
10 mg/day x 5
Intervention Type
Drug
Intervention Name(s)
Campath-1H
Other Intervention Name(s)
Alemutuzumab, Campath
Intervention Description
10 mg/day x 5, starting with the first day of chemotherapy
Primary Outcome Measure Information:
Title
CAMPATH 2-year event-free survival rate
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 15-65 years old B or T-cell lymphoid disease, not eligible for non-myeloablative transplantation. Patients in relapse after failing conventional chemotherapy. Patients with HLA-identical or one-antigen mismatched sibling, or a matched unrelated donor. Performance status </=2. Exclusion Criteria: Past history of anaphylaxis following exposure to rat or mouse derived CDR-grafted humanized monoclonal antibodies. Less than 4 weeks since prior chemotherapy. Pregnancy or lactation. HIV or HTLV-I positivity. Serum creatinine >1.6 mg/dl or serum bilirubin >0.2 mg/dl unless due to tumor, SGPT >/= 2 x NI PFT-DCLO<50%, cardiac EF <50% of predicted levels.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Issa F. Khouri, MD, BS
Organizational Affiliation
UT MD Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
UT MD Anderson Cancer Center website

Learn more about this trial

Campath-1H and Allogeneic Blood Stem Cell Transplantation for Lymphoid Malignancies

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