Acute Myeloid LeukemiaPhase 2NCT00328237
Treatment of Hematologic Malignancies With Single-Unit or Double-Unit Cord Blood Transplantation
A Phase 2 study testing Cord Blood Transplant in people with Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by Colorado Blood Cancer Institute at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the incidence of neutrophil engraftment after transplantation of one or two cord blood units meeting a predetermined total minimum cell dose of 2.0 x 10 to the seventh total nucleated cell (TNC)/kg. Read more about this study
- Who is it for?
- Ages 18 to 49 years
- Conditions the study is for
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myeloid Leukemia
- What is being tested?
- Cord Blood Transplant
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to not given
- Phase
- Phase 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 18 to 49 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients must:
- Be between the ages of 18 and 49 years inclusive.
- Have histologically proven hematologic malignancy and must meet accepted indications for allogeneic stem cell transplantation:
- Acute myeloid leukemia (AML): high-risk in first complete remission (CR), near first CR (< 20% marrow blasts after induction therapy), or beyond first remission.
- Acute lymphoblastic leukemia with high-risk features in first remission (Philadelphia chromosome positive or other similar high-risk features), near first CR (< 20% marrow blasts after induction therapy), or beyond first remission.
- Chronic myeloid leukemia: in chronic phase (CP) and have failed Gleevec or are intolerant and have signs of failing other treatments, or have history of accelerated or blast phases. Storage of autologous peripheral blood stem cells is recommended for this group for patients, particularly if in chronic phase.
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- Non-Hodgkin's lymphoma: aggressive histology with relapsed or primary refractory disease and not eligible for autologous transplantation. Patients with low-grade histology must have either failed 2 or more lines of systemic chemotherapy including one rituximab-based regimen. Radioimmunotherapy will be considered the equivalent of one line of chemotherapy. Excluded if prior radiotherapy to chest or prior autologous transplantation.
- Myelodysplastic syndromes with International Prognostic Scoring System (IPSS) score of 1.5 or greater.
- Other hematological malignancies if approved by the pipeline meeting on a case by case basis. Must also be approved by principal investigator.
- Have no HLA-matched or 1-antigen mismatched related donors and no HLA-matched unrelated stem cell donors, or delays involved in performing a search are likely to be detrimental to the patient.
- Have an ECOG performance status of 0 or 1 at the time of transplant.
- Have major end organs (heart, lungs, liver, and kidneys) assessed and deemed adequate to withstand the effects of high-dose therapy planned for this protocol.
- Have given voluntary informed consent.
Who cannot join
- Patients are ineligible for this protocol if they:
- Have a co-morbid medical condition, a psychiatric condition, or organ dysfunction that makes them at high-risk for treatment failure, for failed medical compliance, or for regimen-related toxicity from high-dose therapy.
- Patients with any of the following will be excluded:
- Pulmonary: hemoglobin (Hb)-adjusted diffusing capacity of lung for carbon monoxide (DLCO) < 60%, forced expiratory volume in 1 second (FEV1) < 70% of predicted, or receive continuous supplemental oxygen;
- Cardiac: left ventricular ejection fraction (LVEF) < 50% or on any treatment for congestive heart failure;
- Renal: serum creatinine greater than 2.0 or calculated creatinine clearance < 50 cc/min;
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- Liver: ALT, AST, or serum bilirubin > 1.5 x upper limit of normal (ULN). Any patient with elevated transaminases should have careful evaluation for the cause and liver biopsy may be required by the principle investigator. An elevated alkaline phosphatase should be fractionated and, if of liver origin, should be evaluated as for transaminases.
- Are female and are pregnant, lactating, or have a positive pregnancy test.
- Have a history of previous malignancy except for non-melanoma skin cancer and in-situ carcinoma of the cervix, unless the patient has been progression-free for > 5 years
- Are HIV positive
- Refractory malignancy: acute leukemia with greater than 30% blasts in bone marrow unless with untreated first relapse of AML or untreated myelodysplastic syndrome evolved to AML.
- Acute leukemia with greater than 1000 blasts/ul in peripheral blood.
- Uncontrolled central nervous system (CNS) leukemia or lymphoma.
- Prior autologous or allogeneic transplantation using a myeloablative regimen.
- Uncontrolled hypertension (systolic blood pressure [SBP] > 140, diastolic blood pressure [DBP] > 90) or hypertension requiring > 2 drugs for good control (SBP < 130, DBP < 90).
- Invasive mold infection that is uncontrolled or has received less than one month of antifungal therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Rocky Mountain Blood and Marrow Transplant Program
Denver, Colorado, 80218
Scott Bearman, MD
Robert Rifkin, MD
About this study
Official title: Treatment of Hematologic Malignancies With High-Dose Chemo-Radiotherapy Followed by Single-Unit or Double-Unit Cord Blood Transplantation: A Phase II Study
The purpose of this study is to evaluate the incidence of neutrophil engraftment after transplantation of one or two cord blood units meeting a predetermined total minimum cell dose of 2.0 x 10 to the seventh total nucleated cell (TNC)/kg.
Read the detailed description
This is a non-randomized, phase II protocol to evaluate engraftment of cord blood after treatment with myeloablative conditioning of fludarabine, total body irradiation and cyclophosphamide. All patients will receive tacrolimus and mycophenolate mofetil as prophylaxis for graft-vs-host disease.
Conditioning Regimen:
- Days -10 to -7: Fludarabine 30mg/m2/day IV
- Days -7 to -4: TBI 165 centigray BID
- Days -3 to -2: Cyclophosphamide 40mg/kg/day IV
Day 0: Infusion of Cord Blood Cells
Graft-vs-Host Disease Prophylaxis
- Day -1: Start tacrolimus 0.03mg/kg/day IV
- Day 0: Start MMF 7.5mg/kg IV BID
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myeloid Leukemia, Non-Hodgkin Lymphoma, Myelodysplastic Syndromes
- Being tested
- Cord Blood Transplant
- Keywords
- Cord Blood Transplant, Umbilical cord blood transplant, Transplant, Fludarabine, Total Body Irradiation, Cyclophosphamide
- Medical subject headings
- Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Lymphoma, Non-Hodgkin, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cord Blood TransplantProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the incidence of neutrophil engraftment after transplantation of one or two cord blood units
Secondary outcomes (5)
Evaluate safety as measured by day 100 treatment related mortality
Evaluate incidence of platelet engraftment
Evaluate incidences of acute and chronic graft-versus-host disease (GVHD)
Evaluate efficacy as measured by survival at 1 and 2 years after transplant
Evaluate chimerism from double cord transplants to determine source of long term engraftment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2006 (estimated)
- Study startNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Colorado Blood Cancer Institute
- Sponsor type
- University, hospital or other
- Investigators
- Peter McSweeney, MD, Principal investigator, Colorado Blood Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00328237
- Sponsor's protocol ID
- RMBMT-149
- Status last verified
- Nov 2005
- First submitted
- 17 May 2006
- Last updated
- 26 Jun 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Hematologic Malignancies With High-Dose Chemo-Radiotherapy Followed by Single-Unit or Double-Unit Cord Blood Transplantation: A Phase II Study
- ClinicalTrials.gov ID
- NCT00328237
- Acronym / sponsor ID
- RMBMT-149
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myeloid Leukemia, Non-Hodgkin Lymphoma, Myelodysplastic Syndromes
- Keywords
- Cord Blood Transplant, Umbilical cord blood transplant, Transplant, Fludarabine, Total Body Irradiation, Cyclophosphamide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants
- Lead sponsor
- Colorado Blood Cancer InstituteUniversity, hospital or other
- Study start
- Nov 2005
- First posted
- 19 May 2006 (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.
The purpose of this study is to evaluate the incidence of neutrophil engraftment after transplantation of one or two cord blood units meeting a predetermined total minimum cell dose of 2.0 x 10 to the seventh total nucleated cell (TNC)/kg.
Detailed description
This is a non-randomized, phase II protocol to evaluate engraftment of cord blood after treatment with myeloablative conditioning of fludarabine, total body irradiation and cyclophosphamide. All patients will receive tacrolimus and mycophenolate mofetil as prophylaxis for graft-vs-host disease.
Conditioning Regimen:
- Days -10 to -7: Fludarabine 30mg/m2/day IV
- Days -7 to -4: TBI 165 centigray BID
- Days -3 to -2: Cyclophosphamide 40mg/kg/day IV
Day 0: Infusion of Cord Blood Cells
Graft-vs-Host Disease Prophylaxis
- Day -1: Start tacrolimus 0.03mg/kg/day IV
- Day 0: Start MMF 7.5mg/kg IV BID
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Be between the ages of 18 and 49 years inclusive.
- Have histologically proven hematologic malignancy and must meet accepted indications for allogeneic stem cell transplantation:
- Have no HLA-matched or 1-antigen mismatched related donors and no HLA-matched unrelated stem cell donors, or delays involved in performing a search are likely to be detrimental to the patient.
- Have an ECOG performance status of 0 or 1 at the time of transplant.
- Have major end organs (heart, lungs, liver, and kidneys) assessed and deemed adequate to withstand the effects of high-dose therapy planned for this protocol.
Key exclusion criteria (16 listed)
- Have a co-morbid medical condition, a psychiatric condition, or organ dysfunction that makes them at high-risk for treatment failure, for failed medical compliance, or for regimen-related toxicity from high-dose therapy.
- Patients with any of the following will be excluded:
- Are female and are pregnant, lactating, or have a positive pregnancy test.
- Have a history of previous malignancy except for non-melanoma skin cancer and in-situ carcinoma of the cervix, unless the patient has been progression-free for > 5 years
- Are HIV positive
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 |
|---|---|---|
| Cord Blood Transplant | Procedure or surgery | – |
Primary outcome
Evaluate the incidence of neutrophil engraftment after transplantation of one or two cord blood units
5 secondary outcomes
Evaluate safety as measured by day 100 treatment related mortality
Evaluate incidence of platelet engraftment
Evaluate incidences of acute and chronic graft-versus-host disease (GVHD)
Evaluate efficacy as measured by survival at 1 and 2 years after transplant
Evaluate chimerism from double cord transplants to determine source of long term engraftment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2006.
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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.
Peter McSweeney, MD principal investigator
Colorado Blood Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cord Blood Transplant in people with Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by Colorado Blood Cancer Institute 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 13 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 26 Jun 2006. 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.
What does this phase mean?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicole Stephens, RN, BSN, OCN (303-336-2183, Nicole.Stephens@USOncology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the incidence of neutrophil engraftment after transplantation of one or two cord blood units. 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 26 Jun 2006.