Graft Versus Host DiseasePhase 1/2NCT00555048
Alemtuzumab, Busulfan, and Cyclophosphamide Followed By a Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer
A Phase 1/2 study testing alemtuzumab, busulfan and cyclophosphamide in people with Graft Versus Host Disease and Leukemia, run by Fred Hutchinson Cancer Center at 2 sites in United States.
Trial summary
RATIONALE: Monoclonal antibodies, such as alemtuzumab, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Giving chemotherapy drugs, such as busulfan and cyclophosphamide, before a donor stem cell transplant helps stop the growth of cancer cells. Read more about this study
- Who is it for?
- Ages Up to 50 years
- Conditions the study is for
- Graft Versus Host Disease, Leukemia, Myelodysplastic Syndromes
- What is being tested?
- alemtuzumab, busulfan and cyclophosphamide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2007to Oct 2010
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- See Disease Characteristics
Who cannot join
- Prior allogeneic or autologous bone marrow, peripheral blood stem cell, or umbilical cord blood transplantation using a high-dose total-body irradiation regimen
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98104-1024
Seattle Cancer Care Alliance
Seattle, Washington, 98109-1023
About this study
Official title: A Prospective Trial to Evaluate the Role of In Vivo T Cell Depletion by Campath® (Alemtuzumab) in Reduction of Transplant Related Mortality in Transplantation From HLA-Class I or Class II Mismatched, Unrelated Donors
RATIONALE: Monoclonal antibodies, such as alemtuzumab, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Giving chemotherapy drugs, such as busulfan and cyclophosphamide, before a donor stem cell transplant helps stop the growth of cancer 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 tacrolimus and methotrexate after the transplant may stop this from happening.
PURPOSE: This phase I/II trial is studying the best dose of alemtuzumab when given together with busulfan and cyclophosphamide followed by a donor stem cell transplant and to see how well it works in treating patients with hematologic cancer.
Read the detailed description
OBJECTIVES:
Primary
- Identify the lowest dose of alemtuzumab that is associated with day 180 transplant-related mortality ≤ 45%.
Secondary
- Determine the incidence of life-threatening infection in patients receiving this treatment.
- Determine the incidence of grades III-IV acute graft-vs-host disease (GVHD) in patients receiving this treatment.
- Determine the survival at 1 year in patients receiving this treatment.
- Determine the incidence of disease relapse at 1 year in patients receiving this treatment.
- Determine the incidence of extensive chronic GVHD at 1 year in patients receiving this treatment.
- Determine the incidence of graft failure at day 100 in patients receiving this treatment.
OUTLINE:
- Chemotherapy: Patients receive alemtuzumab IV over 2 hours on days -10 to -6, busulfan IV over 3 hours on days -7 to -4, and cyclophosphamide IV on days -3 and -2.
- Peripheral blood stem cell (PBSC) transplantation: Patients undergo allogeneic filgrastim (G-CSF)-mobilized PBSC transplantation on day 0.
- Graft-vs-host disease prophylaxis: Patients receive tacrolimus IV continuously or orally twice daily on days -1 to 50 and methotrexate IV on days 1, 3, 6, and 11.
After completion of study therapy, patients are followed periodically.
- Conditions
- Graft Versus Host Disease, Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases
- Being tested
- alemtuzumab, busulfan, cyclophosphamide, methotrexate, tacrolimus
- Keywords
- graft versus host disease, adult acute megakaryoblastic leukemia (M7), adult acute monoblastic leukemia (M5a), adult acute monocytic leukemia (M5b), adult acute myeloblastic leukemia with maturation (M2), adult acute myeloblastic leukemia without maturation (M1), adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myelomonocytic leukemia (M4), adult acute promyelocytic leukemia (M3), adult erythroleukemia (M6a), adult pure erythroid leukemia (M6b), childhood acute megakaryocytic leukemia (M7), childhood acute monoblastic leukemia (M5a), childhood acute monocytic leukemia (M5b), childhood acute myeloblastic leukemia with maturation (M2), childhood acute myeloblastic leukemia without maturation (M1), childhood acute myelomonocytic leukemia (M4), childhood acute promyelocytic leukemia (M3), accelerated phase chronic myelogenous leukemia, adult acute lymphoblastic leukemia in remission
- Medical subject headings
- Graft vs Host Disease, Leukemia, Myelodysplastic Syndromes, Myelodysplastic-Myeloproliferative Diseases, Leukemia, Megakaryoblastic, Acute, Leukemia, Monocytic, Acute, Leukemia, Myeloid, Acute, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alemtuzumabBiological
busulfanDrug
cyclophosphamideDrug
methotrexateDrug
tacrolimusDrug
allogeneic hematopoietic stem cell transplantationProcedure or surgery
peripheral blood stem cell transplantationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Alemtuzumab | Experimental | Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant. Receives: Biological: alemtuzumab; Drug: busulfan; Drug: cyclophosphamide; Drug: methotrexate; Drug: tacrolimus; Procedure: allogeneic hematopoietic stem cell transplantation; Procedure: peripheral blood stem cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lowest Dose of Alemtuzumab Associated With Transplant-related Mortality
Lowest dose of alemtuzumab associated with transplant-related mortality at day 180
Measured: Up to day 180
Secondary outcomes (6)
Life-threatening Infection
Measured: Up to 180 days
Grades III-IV Acute Graft-vs-host Disease (GVHD)
Measured: Up to 100 days
Overall Survival
Count of surviving participants at 1 year
Measured: Up to 1 year
Disease Relapse
Count of participants with disease relapse at 1 year
Measured: Up to 1 year
Extensive Chronic GVHD
Count of participants with extensive chronic GVHD at 1 year
Measured: Up to 1 year
Graft Failure
Count of participants with graft failure at day 100
Measured: Up to day 100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2007 (estimated)
- Study startSep 2007
- Primary completionOct 2010
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Graft Versus Host DiseaseStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Ann Woolfrey, Fred Hutchinson Cancer Center
- Investigators
- Ann E. Woolfrey, MD, Principal investigator, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00555048
- Sponsor's protocol ID
- 1981.00
- Other IDs
- P30CA015704, FHCRC-1981.00, CDR0000574145
- Status last verified
- Apr 2017
- First submitted
- 6 Nov 2007
- Last updated
- 24 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Trial to Evaluate the Role of In Vivo T Cell Depletion by Campath® (Alemtuzumab) in Reduction of Transplant Related Mortality in Transplantation From HLA-Class I or Class II Mismatched, Unrelated Donors
- ClinicalTrials.gov ID
- NCT00555048
- Acronym / sponsor ID
- 1981.00
- Conditions
- Graft Versus Host Disease, Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases
- Keywords
- graft versus host disease, adult acute megakaryoblastic leukemia (M7), adult acute monoblastic leukemia (M5a), adult acute monocytic leukemia (M5b), adult acute myeloblastic leukemia with maturation (M2), adult acute myeloblastic leukemia without maturation (M1), adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myelomonocytic leukemia (M4)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2007
- Primary completion
- Oct 2010 (actual)
- First posted
- 7 Nov 2007 (estimated)
- Results
- Posted 24 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Monoclonal antibodies, such as alemtuzumab, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Giving chemotherapy drugs, such as busulfan and cyclophosphamide, before a donor stem cell transplant helps stop the growth of cancer 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 tacrolimus and methotrexate after the transplant may stop this from happening.
PURPOSE: This phase I/II trial is studying the best dose of alemtuzumab when given together with busulfan and cyclophosphamide followed by a donor stem cell transplant and to see how well it works in treating patients with hematologic cancer.
Detailed description
OBJECTIVES:
Primary
- Identify the lowest dose of alemtuzumab that is associated with day 180 transplant-related mortality ≤ 45%.
Secondary
- Determine the incidence of life-threatening infection in patients receiving this treatment.
- Determine the incidence of grades III-IV acute graft-vs-host disease (GVHD) in patients receiving this treatment.
- Determine the survival at 1 year in patients receiving this treatment.
- Determine the incidence of disease relapse at 1 year in patients receiving this treatment.
- Determine the incidence of extensive chronic GVHD at 1 year in patients receiving this treatment.
- Determine the incidence of graft failure at day 100 in patients receiving this treatment.
OUTLINE:
- Chemotherapy: Patients receive alemtuzumab IV over 2 hours on days -10 to -6, busulfan IV over 3 hours on days -7 to -4, and cyclophosphamide IV on days -3 and -2.
- Peripheral blood stem cell (PBSC) transplantation: Patients undergo allogeneic filgrastim (G-CSF)-mobilized PBSC transplantation on day 0.
- Graft-vs-host disease prophylaxis: Patients receive tacrolimus IV continuously or orally twice daily on days -1 to 50 and methotrexate IV on days 1, 3, 6, and 11.
After completion of study therapy, patients are followed periodically.
Study design
- Primary purpose
- Treatment
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alemtuzumab | Experimental | Biological: alemtuzumab, Drug: busulfan, Drug: cyclophosphamide, Drug: methotrexate, Drug: tacrolimus, Procedure: allogeneic hematopoietic stem cell transplantation, Procedure: peripheral blood stem cell transplantationAlemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant. |
Who may qualify
- Ages
- Up to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- See Disease Characteristics
Key exclusion criteria (1 listed)
- Prior allogeneic or autologous bone marrow, peripheral blood stem cell, or umbilical cord blood transplantation using a high-dose total-body irradiation regimen
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 |
|---|---|---|
| alemtuzumab | Biological | Alemtuzumab |
| busulfan | Drug | Alemtuzumab |
| cyclophosphamide | Drug | Alemtuzumab |
| methotrexate | Drug | Alemtuzumab |
| tacrolimus | Drug | Alemtuzumab |
| allogeneic hematopoietic stem cell transplantation | Procedure or surgery | Alemtuzumab |
| peripheral blood stem cell transplantation | Procedure or surgery | Alemtuzumab |
Primary outcome
Lowest Dose of Alemtuzumab Associated With Transplant-related Mortality
Time frame: Up to day 180
Lowest dose of alemtuzumab associated with transplant-related mortality at day 180
6 secondary outcomes
Life-threatening Infection
Time frame: Up to 180 days
Grades III-IV Acute Graft-vs-host Disease (GVHD)
Time frame: Up to 100 days
Overall Survival
Time frame: Up to 1 year
Disease Relapse
Time frame: Up to 1 year
Extensive Chronic GVHD
Time frame: Up to 1 year
Graft Failure
Time frame: Up to day 100
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ann E. Woolfrey, MD principal investigator
Fred Hutchinson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing alemtuzumab, busulfan and cyclophosphamide in people with Graft Versus Host Disease and Leukemia, run by Fred Hutchinson Cancer Center at 2 sites 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 1 inclusion and 1 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 24 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Lowest Dose of Alemtuzumab Associated With Transplant-related Mortality (time frame: Up to day 180). 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 24 May 2017; AzTrials last refreshed its copy on 26 Oct 2026.