Myelodysplastic DisordersPhase 1/2NCT00048412
Stem Cell Transplant for Patients With Blood Malignancy Using Donors and Less Toxic Chemotherapy With CAMPATH 1H
A Phase 1/2 study testing FLUDARABINE, CAMPATH 1H and FK50 in people with Myelodysplastic Disorders and Leukemia, run by Baylor College of Medicine at 2 sites in United States.
Trial summary
1. To assess the treatment related mortality of allogeneic stem cell transplantation with non-myeloablative therapy incorporating the lymphodepleting MAb CAMPATH-1H, in patients with hematological diseases and renal cell carcinoma not eligible for conventional (myeloablative) therapy. 2. Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Myelodysplastic Disorders, Leukemia, Multiple Myeloma
- What is being tested?
- FLUDARABINE, CAMPATH 1H and FK50
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2000to 12 Nov 2004
- Phase
- Phase 1/2
- 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 Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of myelodysplastic disorders, Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Multiple Myeloma, Plasma Cell Dyscrasia, Lymphoproliferative disorders (Non-Hodgkin Lymphoma, Hairy Cell Leukemia, Chronic Lymphocytic Leukemia and Hodgkins Disease) or Renal Cell Carcinoma.
- Conditions that increase treatment related mortality (need one or more to be eligible):
- Greater to or equal to 50 years of age.
- EF of less than 45%
- DLCO less than 50% of FEV1 50-75% of predicted value.
- Diabetes Mellitus
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- Renal Insufficiency (but creatine clearance not less than 25ml/min).
- Prior recent history of systemic fungal infection.
- 3rd or greater remission of AML or ALL
- More than 1 year of diagnosis (CML or Myeloma patients)
- Multiple types of treatment regimens. (equal to or more than 3)
- Prior autologous or allogeneic stem cell transplantation.
- Significant grade III or IV neurologic or hepatic toxicity from previous treatment.
- No matched sibling donor.
- Available healthy donor without any contraindications for donation. 5/6 or 6/6 related donor. 5/6 or 6/6 unrelated donor (molecular typing for DRB1)
- Patient and/or responsible person able to understand consent.
- Age between birth and 70 years.
- For women of childbearing potential, negative pregnancy test.
Who cannot join
- Patient is pregnant, lactating or unwilling to use contraceptives
- HIV positive patient
- Uncontrolled intercurrent infection
- Refractory AML, or ALL
- Untreated Blast Crisis for CML
- Uncontrolled High-grade lymphoproliferative disease/lymphoma.
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- Unstable angina and uncompensated congestive heart failure (Zubrod of 3 or greater)
- Severe chronic pulmonary disease requiring oxygen (Zubrod of 3 or greater)
- Hemodialysis dependent
- Active Hepatitis or cirrhosis with total bilirubin, SGOT, and SGPT greater than 3 x normal.
- Unstable Cerebral vascular disease and recent hemorrhagic stroke (less than 6 months)
- Active CNS disease from hematological disorder.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Texas Children's Hospital
Houston, Texas, 77030
The Methodist Hospital
Houston, Texas, 77030
About this study
Official title: Phase I/II Study of Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancy, Using MHC Identical or Near Identical Donors and Sub-Myeloablative Conditioning With CAMPATH 1H (DIMSUM)
- To assess the treatment related mortality of allogeneic stem cell transplantation with non-myeloablative therapy incorporating the lymphodepleting MAb CAMPATH-1H, in patients with hematological diseases and renal cell carcinoma not eligible for conventional (myeloablative) therapy.
- To assess the time to engraftment and incidence of graft failure in patients receiving this transplant regimen.
- To assess the safety, pharmacokinetics and immunologic activity of CAMPATH-1H when used as part of a subablative conditioning regimen.
Read the detailed description
This is a two arm study in which outcomes will be assessed independently in recipients of HLA matched sibling transplants and recipients of unrelated or mismatched family donor transplants, although both groups will receive identical treatments.
The following will be given to the patient after admission:
Day - 6: Total body irradiation
Day - 5 to - 2: Fludarabine and Campath 1H
Day - 1: Day of rest
Day 0: Stem cell transplant (infusion)
- Conditions
- Myelodysplastic Disorders, Leukemia, Multiple Myeloma, Plasma Cell Dyscrasia, Lymphoproliferative Disorders
- Being tested
- FLUDARABINE, CAMPATH 1H, FK50, Stem Cell Collection and Infusion
- Medical subject headings
- Leukemia, Multiple Myeloma, Paraproteinemias, Lymphoproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLUDARABINEDrug
CAMPATH 1HDrug
FK50Drug
Stem Cell Collection and InfusionProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2002 (estimated)
- Study startJun 2000
- Primary completion12 Nov 2004
- Study completion12 Nov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic DisordersStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The Methodist Hospital Research Institute, Center for Cell and Gene Therapy, Baylor College of Medicine
- Responsible party
- Principal investigator, George Carrum, Baylor College of Medicine
- Investigators
- George Carrum, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00048412
- Sponsor's protocol ID
- H8714
- Other IDs
- DIMSUM
- Status last verified
- Jan 2020
- First submitted
- 30 Oct 2002
- Last updated
- 18 Jan 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancy, Using MHC Identical or Near Identical Donors and Sub-Myeloablative Conditioning With CAMPATH 1H (DIMSUM)
- ClinicalTrials.gov ID
- NCT00048412
- Acronym / sponsor ID
- H8714
- Conditions
- Myelodysplastic Disorders, Leukemia, Multiple Myeloma, Plasma Cell Dyscrasia, Lymphoproliferative Disorders
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- The Methodist Hospital Research Institute, Center for Cell and Gene Therapy, Baylor College of Medicine
- Study start
- Jun 2000
- Primary completion
- 12 Nov 2004 (actual)
- Study completion
- 12 Nov 2004 (actual)
- First posted
- 1 Nov 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.
- To assess the treatment related mortality of allogeneic stem cell transplantation with non-myeloablative therapy incorporating the lymphodepleting MAb CAMPATH-1H, in patients with hematological diseases and renal cell carcinoma not eligible for conventional (myeloablative) therapy.
- To assess the time to engraftment and incidence of graft failure in patients receiving this transplant regimen.
- To assess the safety, pharmacokinetics and immunologic activity of CAMPATH-1H when used as part of a subablative conditioning regimen.
Detailed description
This is a two arm study in which outcomes will be assessed independently in recipients of HLA matched sibling transplants and recipients of unrelated or mismatched family donor transplants, although both groups will receive identical treatments.
The following will be given to the patient after admission:
Day - 6: Total body irradiation
Day - 5 to - 2: Fludarabine and Campath 1H
Day - 1: Day of rest
Day 0: Stem cell transplant (infusion)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (18 listed)
- Diagnosis of myelodysplastic disorders, Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Multiple Myeloma, Plasma Cell Dyscrasia, Lymphoproliferative disorders (Non-Hodgkin Lymphoma, Hairy Cell Leukemia, Chronic Lymphocytic Leukemia and Hodgkins Disease) or Renal Cell Carcinoma.
- Conditions that increase treatment related mortality (need one or more to be eligible):
- Available healthy donor without any contraindications for donation. 5/6 or 6/6 related donor. 5/6 or 6/6 unrelated donor (molecular typing for DRB1)
- Patient and/or responsible person able to understand consent.
- Age between birth and 70 years.
Key exclusion criteria (12 listed)
- Patient is pregnant, lactating or unwilling to use contraceptives
- HIV positive patient
- Uncontrolled intercurrent infection
- Refractory AML, or ALL
- Untreated Blast Crisis for CML
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 |
|---|---|---|
| FLUDARABINE | Drug | – |
| CAMPATH 1H | Drug | – |
| FK50 | Drug | – |
| Stem Cell Collection and Infusion | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
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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.
George Carrum, MD principal investigator
Baylor College of Medicine
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 FLUDARABINE, CAMPATH 1H and FK50 in people with Myelodysplastic Disorders and Leukemia, run by Baylor College of Medicine 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 18 inclusion and 12 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: finished, as of the sponsor's last update on 18 Jan 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 18 Jan 2020; AzTrials last refreshed its copy on 4 Nov 2026.