Leukemia, Lymphocytic, ChronicNCT00038883
Campath-1H and Allogeneic Blood Stem Cell Transplantation for Lymphoid Malignancies
A study testing Campath-1H in people with Leukemia, Lymphocytic, Chronic and Leukemia, Lymphocytic, Acute, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Leukemia, Lymphocytic, Chronic, Leukemia, Lymphocytic, Acute, Lymphoma, Low-Grade
- What is being tested?
- Campath-1H
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2001to May 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Campath-1H Snd Allogeneic Blood Stem Cell Transplantation for Lymphoid Malignancies
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.
Read the 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.
- Conditions
- Leukemia, Lymphocytic, Chronic, Leukemia, Lymphocytic, Acute, Lymphoma, Low-Grade, Lymphoma, T-Cell, Lymphoma, B-Cell
- Being tested
- Campath-1H
- Keywords
- Lymphoid Malignancies, Chronic Lymphocytic Leukemia, Acute Lymphoblastic Leukemia, Low grade Lymphoma, B and T cell Lymphoma of the intermediate and high grade
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Non-Hodgkin, Lymphoma, T-Cell, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Campath-1HDrug
Also called Alemutuzumab, Campath
10 mg/day x 5, starting with the first day of chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Campath-1H | Experimental | 10 mg/day x 5 Receives: Drug: Campath-1H |
What is being measured
The primary outcome is the main question the study is designed to answer.
CAMPATH 2-year event-free survival rate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2002 (estimated)
- Study start9 Apr 2001
- Primary completionMay 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Lymphocytic, ChronicStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Leudosite
- Responsible party
- Sponsor
- Investigators
- Issa F. Khouri, MD, BS, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00038883
- Sponsor's protocol ID
- ID99-410
- Status last verified
- Nov 2018
- First submitted
- 5 Jun 2002
- Last updated
- 7 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Campath-1H Snd Allogeneic Blood Stem Cell Transplantation for Lymphoid Malignancies
- ClinicalTrials.gov ID
- NCT00038883
- Acronym / sponsor ID
- ID99-410
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 19 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Leudosite
- Study start
- 9 Apr 2001 (actual)
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 7 Jun 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Campath-1H | Experimental | Drug: Campath-1H10 mg/day x 5 |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Campath-1HAlso: Alemutuzumab, Campath10 mg/day x 5, starting with the first day of chemotherapy | Drug | Campath-1H |
Primary outcome
CAMPATH 2-year event-free survival rate
Time frame: 2 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Issa F. Khouri, MD, BS principal investigator
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Campath-1H in people with Leukemia, Lymphocytic, Chronic and Leukemia, Lymphocytic, Acute, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CAMPATH 2-year event-free survival rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2018.