LeukemiaNCT00547196
AlloHCT From Matched Unrelated Donors in Pts w/ Advanced Hematologic Malignancies & Disorders
A study testing filgrastim, Busulfan and Cyclophosphamide in people with Leukemia and Lymphoma, run by City of Hope Medical Center at 2 sites in United States.
Trial summary
RATIONALE: Giving chemotherapy with or without total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. Read more about this study
- Who is it for?
- Ages 0 to 120 years
- Conditions the study is for
- Leukemia, Lymphoma, Myelodysplastic Syndromes
- What is being tested?
- filgrastim, Busulfan and Cyclophosphamide
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Aug 2005to 28 May 2024
- Phase
- Interventional
- 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 0 to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed hematological or lymphatic malignancy, including any of the following:
- Acute myeloid leukemia
- Relapsed or primary refractory disease with < 10% blasts on peripheral blood smear
- In first remission with poor risk factors and molecular prognosis [i.e., AML with -5, -7, t(6;9), tri8, -11] (preparative regimen 3 or 4)
- Acute lymphocytic leukemia
- In second complete remission or higher OR in first remission with poor risk factors, including any of the following (preparative regimen 1 or 2):
- BCR/ABL by fluorescence in situ hybridization (FISH) or reverse transcriptase-polymerase chain reaction
- t(9;22)(q34;q11) detected by cytogenetics
- Chromosomes < 44 by cytogenetics
- DNA index < 0.81 by flow cytometry
- Any rearrangement of chromosome 11 that results in disruption of MLL gene (11q23) by cytogenetics and SER
- In first remission with poor risk factors and molecular prognosis [ALL with Philadelphia chromosome-positive t(9;22), t(4;22), (q34;q11)] (preparative regimen 3 or 4)
- Chronic myelogenous leukemia
- In accelerated phase or greater (preparative regimen 1 or 2)
- In accelerated or second chronic phase (preparative regimen 3 or 4)
- Myelodysplastic syndromes
- With deletion of chromosome 7 or short arm of chromosome 5 (preparative regimen 1 or 2)
- In high and high-intermediate risk categories (preparative regimen 3 or 4)
- Non-Hodgkin lymphoma in relapse with marrow involvement
- Refractory chronic lymphocytic leukemia
- Patients deemed ineligible for conventional high-dose chemotherapy programs (i.e., regimens 1 or 2) due to any of the following concurrent medical conditions may be eligible for regimens 3 or 4 at the discretion of the treating physician and principal investigator (preparative regimen 3 or 4):
- LVEF < 50% and > 40%
- FEV1, FVC, or DLCO < 50%
- Bilirubin > 3 mg/dL
- Creatinine > 2 mg/dL
- Two partially HLA-matched umbilical cord blood (UCB) units available
- HLA-matched minimally at 4 of 6 HLA-A, HLA-B, and -DRB1 loci with the patient
- DRB1 matched by high resolution DNA typing
- HLA-A and HLA-B matched by low resolution at the "serological match" level
- Two pooled units with a nucleated cell number > 2.5 x 10^7/kg
- No available HLA-identical sibling or 1 antigen-mismatched related donor
- No available HLA-matched unrelated bone marrow donor
PATIENT CHARACTERISTICS:
- See Disease Characteristics
- Karnofsky performance status (PS) 60-100% OR Lansky PS 60-100% OR Zubrod PS 0-1
- Physiological age 60 or less (at any chronological age)
- Weight > 50 kg
- Creatinine normal for age OR creatinine clearance by 24-hour urine collection or glomerular filtration rate > 60 mL/min
- Bilirubin ≤ 1.5 mg/dL
- LVEF ≥ 50%
- DLCO ≥ 60% of predicted
- No HIV-1 infection
- No active uncontrolled infection
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- Recovered from prior intensive chemotherapy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
City of Hope Medical Center
Duarte, California, 91010-3000
Banner Good Samaritan Medical Center
Phoenix, Arizona, 85006
About this study
Official title: Allogeneic Stem Cell Transplantation for Patients With Hematological Malignancies Using Multiple Unrelated Cord Blood Units
RATIONALE: Giving chemotherapy with or without total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the 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 cyclosporine and mycophenolate mofetil before and after transplant may stop this from happening.
PURPOSE: This clinical trial is studying how well four different chemotherapy regimens given with or without total-body irradiation before umbilical cord blood transplant work in treating patients with relapsed or refractory hematologic cancer.
Read the detailed description
OBJECTIVES:
Primary
- To determine the survival at day 100 of patients with relapsed, refractory, or poor-risk hematological malignancies treated with four different preparative regimens followed by allogeneic hematopoietic stem cell transplantation (HSCT) using two unrelated umbilical cord blood (UCB) units.
Secondary
- To determine the incidence and timing of neutrophil engraftment in patients treated with these regimens.
- To determine the incidence and timing of platelet engraftment in patients treated with these regimens.
- To determine the incidence and severity of acute and chronic graft-versus-host-disease (GVHD) in patients treated with these regimens.
- To determine the survival at day 180 in patients treated with these regimens.
- To determine the disease-free survival in patients treated with these regimens.
- To determine the incidence of primary and secondary engraftment failure in patients treated with these regimens.
- To determine the incidence of transplantation-related complications (e.g., infection, veno-occlusive disease of the liver, or organ toxicity) in these patients.
- To determine the incidence of post-transplantation-related lymphoproliferative disease, secondary myelodysplastic syndromes, or other secondary malignancies in these patients.
- To determine the incidence of relapse in patients treated with these regimens.
- To determine post-transplantation chimerism in patients treated with these regimens.
- To determine immune reconstitution in patients treated with these regimens.
OUTLINE: This is a multicenter study.
- Preparative regimens: Patients are assigned to 1 of 4 preparative regimens.
- Regimen 1 (for patients < 50 years of age and no contraindication to fractionated total-body irradiation (FTBI): Patients undergo FTBI 2-3 times a day on days -9 to -6 for a total of 11 fractions. Patients also receive cyclophosphamide IV over 2 hours on days -5 and -4 and fludarabine phosphate IV on days -5 to -2.
- Regimen 2 (for patients < 50 years of age and unable to tolerate FTBI due to prior dose-limiting radiotherapy or significant cardiotoxicity): Patients receive a test dose of busulfan on day -10 and then dose adjusted busulfan IV 3-4 times daily on days -9 to -6, melphalan IV on days -5 and -4, and fludarabine phosphate IV on days -5 to -2.
- Regimen 3* (for patients unable to tolerate regimen 1 or 2; no age exclusion): Patients receive fludarabine phosphate IV on days -8 to -4 and cyclophosphamide IV over 2 hours on day -3 and undergo TBI (single dose) on day -2.
- Regimen 4* (for patients unable to tolerate regimen 1 or 2): Patients receive fludarabine phosphate IV on days -7 to -3 and melphalan IV on day -2.
NOTE: *Treating physician decides the choice between regimen 3 and 4
- Umbilical cord blood (UCB) transplantation: Patients receive 2 combined units of UCB IV on day 0. Patients also receive G-CSF IV or subcutaneously beginning on day 5 (or later) and continuing until blood counts recover.
- Graft-versus-host-disease prophylaxis: Patients receive cyclosporine IV twice daily beginning on day -1 followed by a taper according to institutional guidelines. Patients also receive mycophenolate mofetil orally or IV beginning on day 0 and continuing until day 27 (or as clinically indicated).
After completion of study therapy, patients are followed periodically.
- Conditions
- Leukemia, Lymphoma, Myelodysplastic Syndromes
- Being tested
- filgrastim, Busulfan, Cyclophosphamide, Cyclosporine, Fludarabine phosphate
- Keywords
- refractory chronic lymphocytic leukemia, adult acute myeloid leukemia in remission, recurrent adult acute myeloid leukemia, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute lymphoblastic leukemia in remission, accelerated phase chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, recurrent adult Burkitt lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult grade III lymphomatoid granulomatosis
- Medical subject headings
- Leukemia, Lymphoma, Myelodysplastic Syndromes, Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Myeloid, Acute, Congenital Abnormalities, Leukemia, Myeloid, Accelerated Phase, Blast Crisis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastimBiological
BusulfanDrug
Also called Busilvex
CyclophosphamideDrug
Also called CTX
CyclosporineDrug
Also called CsA
Also called Fludara
MelphalanDrug
Also called Alkeran
Also called MMF
allogeneic hematopoietic stem cell transplantationProcedure or surgery
Also called AlloHCT
umbilical cord blood transplantationProcedure or surgery
total-body irradiationRadiation
Also called TBI
Fractionated total body irradiationRadiation
Also called FTBI
| Study group | Role | What they receive |
|---|---|---|
| Regimen I (FTBI, Cyclophosphamide, Fludarabine) | Experimental | Patients undergo FTBI 2-3 times a day on days -9 to -6 for a total of 11 fractions. Patients also receive cyclophosphamide IV over 2 hours on days -5 and -4 and fludarabine phosphate IV on days -5 to -2. UCB transplantation: Patients receive 2 combined units of UCB IV on day 0. Patients also receive G-CSF IV or subcutaneously beginning on day 5 (or later) and continuing until blood counts recover. GVHD prophylaxis: Patients receive cyclosporine IV twice daily beginning on day -1 followed by a taper according to institutional guidelines. Patients also receive mycophenolate mofetil orally or IV beginning on day 0 and continuing until day 27 (or as clinically indicated). Receives: Biological: filgrastim; Drug: Cyclophosphamide; Drug: Cyclosporine; Drug: Fludarabine phosphate; Drug: Mycophenolate Mofetil; Procedure: allogeneic hematopoietic stem cell transplantation; Procedure: umbilical cord blood transplantation; Radiation: Fractionated total body irradiation |
| Regimen II (Busulfan, Fludarabine, Melphalan) | Experimental | Patients receive a test dose of busulfan on day -10 and then dose adjusted busulfan IV 3-4 times daily on days -9 to -6, melphalan IV on days -5 and -4, and fludarabine phosphate IV on days -5 to -2. UCB transplantation: Patients receive 2 combined units of UCB IV on day 0. Patients also receive G-CSF IV or subcutaneously beginning on day 5 (or later) and continuing until blood counts recover. GVHD prophylaxis: Patients receive cyclosporine IV twice daily beginning on day -1 followed by a taper according to institutional guidelines. Patients also receive mycophenolate mofetil orally or IV beginning on day 0 and continuing until day 27 (or as clinically indicated). Receives: Biological: filgrastim; Drug: Busulfan; Drug: Cyclosporine; Drug: Fludarabine phosphate; Drug: Melphalan; Drug: Mycophenolate Mofetil; Procedure: allogeneic hematopoietic stem cell transplantation; Procedure: umbilical cord blood transplantation |
| Regimen III (TBI, Cyclophosphamide, Fludarabine) | Experimental | Patients receive fludarabine phosphate IV on days -8 to -4 and cyclophosphamide IV over 2 hours on day -3 and undergo TBI (single dose) on day -2. UCB transplantation: Patients receive 2 combined units of UCB IV on day 0. Patients also receive G-CSF IV or subcutaneously beginning on day 5 (or later) and continuing until blood counts recover. GVHD prophylaxis: Patients receive cyclosporine IV twice daily beginning on day -1 followed by a taper according to institutional guidelines. Patients also receive mycophenolate mofetil orally or IV beginning on day 0 and continuing until day 27 (or as clinically indicated). Receives: Biological: filgrastim; Drug: Cyclophosphamide; Drug: Cyclosporine; Drug: Fludarabine phosphate; Drug: Mycophenolate Mofetil; Procedure: allogeneic hematopoietic stem cell transplantation; Procedure: umbilical cord blood transplantation; Radiation: total-body irradiation |
| Regimen IV (Fludarabine, Melphalan) | Experimental | Patients receive fludarabine phosphate IV on days -7 to -3 and melphalan IV on day -2. UCB transplantation: Patients receive 2 combined units of UCB IV on day 0. Patients also receive G-CSF IV or subcutaneously beginning on day 5 (or later) and continuing until blood counts recover. GVHD prophylaxis: Patients receive cyclosporine IV twice daily beginning on day -1 followed by a taper according to institutional guidelines. Patients also receive mycophenolate mofetil orally or IV beginning on day 0 and continuing until day 27 (or as clinically indicated). Receives: Biological: filgrastim; Drug: Cyclosporine; Drug: Fludarabine phosphate; Drug: Melphalan; Drug: Mycophenolate Mofetil; Procedure: allogeneic hematopoietic stem cell transplantation; Procedure: umbilical cord blood transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival Rate at Day 100 After Allogeneic Transplant From Umbilical Cord Blood (UCB)
Number of surviving patients at Day 100 post-transplant divided by number of patients undergone transplantation.
Measured: From transplant to Day 100 post-transplant
Secondary outcomes (1)
Survival Rate at Day 180 After Allogeneic Transplant From Umbilical Cord Blood (UCB)
Number of surviving patients at Day 180 post-transplant divided by number of patients undergone transplantation.
Measured: From transplant up to Day 180 post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2007 (estimated)
- Study start16 Aug 2005
- Primary completion11 Nov 2009
- Study completion28 May 2024
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 LeukemiaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Anna Pawlowska, MD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00547196
- Sponsor's protocol ID
- 02165
- Other IDs
- P30CA033572, CHNMC-02165, CDR0000570249
- Status last verified
- Jun 2024
- First submitted
- 19 Oct 2007
- Last updated
- 14 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Stem Cell Transplantation for Patients With Hematological Malignancies Using Multiple Unrelated Cord Blood Units
- ClinicalTrials.gov ID
- NCT00547196
- Acronym / sponsor ID
- 02165
- Conditions
- Leukemia, Lymphoma, Myelodysplastic Syndromes
- Keywords
- refractory chronic lymphocytic leukemia, adult acute myeloid leukemia in remission, recurrent adult acute myeloid leukemia, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 16 Aug 2005 (actual)
- Primary completion
- 11 Nov 2009 (actual)
- Study completion
- 28 May 2024 (actual)
- First posted
- 22 Oct 2007 (estimated)
- Results
- Posted 13 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Giving chemotherapy with or without total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the 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 cyclosporine and mycophenolate mofetil before and after transplant may stop this from happening.
PURPOSE: This clinical trial is studying how well four different chemotherapy regimens given with or without total-body irradiation before umbilical cord blood transplant work in treating patients with relapsed or refractory hematologic cancer.
Detailed description
OBJECTIVES:
Primary
- To determine the survival at day 100 of patients with relapsed, refractory, or poor-risk hematological malignancies treated with four different preparative regimens followed by allogeneic hematopoietic stem cell transplantation (HSCT) using two unrelated umbilical cord blood (UCB) units.
Secondary
- To determine the incidence and timing of neutrophil engraftment in patients treated with these regimens.
- To determine the incidence and timing of platelet engraftment in patients treated with these regimens.
- To determine the incidence and severity of acute and chronic graft-versus-host-disease (GVHD) in patients treated with these regimens.
- To determine the survival at day 180 in patients treated with these regimens.
- To determine the disease-free survival in patients treated with these regimens.
- To determine the incidence of primary and secondary engraftment failure in patients treated with these regimens.
- To determine the incidence of transplantation-related complications (e.g., infection, veno-occlusive disease of the liver, or organ toxicity) in these patients.
- To determine the incidence of post-transplantation-related lymphoproliferative disease, secondary myelodysplastic syndromes, or other secondary malignancies in these patients.
- To determine the incidence of relapse in patients treated with these regimens.
- To determine post-transplantation chimerism in patients treated with these regimens.
- To determine immune reconstitution in patients treated with these regimens.
OUTLINE: This is a multicenter study.
- Preparative regimens: Patients are assigned to 1 of 4 preparative regimens.
- Regimen 1 (for patients < 50 years of age and no contraindication to fractionated total-body irradiation (FTBI): Patients undergo FTBI 2-3 times a day on days -9 to -6 for a total of 11 fractions. Patients also receive cyclophosphamide IV over 2 hours on days -5 and -4 and fludarabine phosphate IV on days -5 to -2.
- Regimen 2 (for patients < 50 years of age and unable to tolerate FTBI due to prior dose-limiting radiotherapy or significant cardiotoxicity): Patients receive a test dose of busulfan on day -10 and then dose adjusted busulfan IV 3-4 times daily on days -9 to -6, melphalan IV on days -5 and -4, and fludarabine phosphate IV on days -5 to -2.
- Regimen 3* (for patients unable to tolerate regimen 1 or 2; no age exclusion): Patients receive fludarabine phosphate IV on days -8 to -4 and cyclophosphamide IV over 2 hours on day -3 and undergo TBI (single dose) on day -2.
- Regimen 4* (for patients unable to tolerate regimen 1 or 2): Patients receive fludarabine phosphate IV on days -7 to -3 and melphalan IV on day -2.
NOTE: *Treating physician decides the choice between regimen 3 and 4
- Umbilical cord blood (UCB) transplantation: Patients receive 2 combined units of UCB IV on day 0. Patients also receive G-CSF IV or subcutaneously beginning on day 5 (or later) and continuing until blood counts recover.
- Graft-versus-host-disease prophylaxis: Patients receive cyclosporine IV twice daily beginning on day -1 followed by a taper according to institutional guidelines. Patients also receive mycophenolate mofetil orally or IV beginning on day 0 and continuing until day 27 (or as clinically indicated).
After completion of study therapy, patients are followed periodically.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Regimen I (FTBI, Cyclophosphamide, Fludarabine) | Experimental | Biological: filgrastim, Drug: Cyclophosphamide, Drug: Cyclosporine, Drug: Fludarabine phosphate, Drug: Mycophenolate Mofetil, Procedure: allogeneic hematopoietic stem cell transplantation, Procedure: umbilical cord blood transplantation, Radiation: Fractionated total body irradiationPatients undergo FTBI 2-3 times a day on days -9 to -6 for a total of 11 fractions. Patients also receive cyclophosphamide IV over 2 hours on days -5 and -4 and fludarabine phosphate IV on days -5 to -2. UCB transplantation: Patients receive 2 combined units of UCB IV on day 0. Patients also receive G-CSF IV or subcutaneously beginning on day 5 (or later) and continuing until blood counts recover. GVHD prophylaxis: Patients receive cyclosporine IV twice daily beginning on day -1 followed by a taper according to institutional guidelines. Patients also receive mycophenolate mofetil orally or IV beginning on day 0 and continuing until day 27 (or as clinically indicated). |
| Regimen II (Busulfan, Fludarabine, Melphalan) | Experimental | Biological: filgrastim, Drug: Busulfan, Drug: Cyclosporine, Drug: Fludarabine phosphate, Drug: Melphalan, Drug: Mycophenolate Mofetil, Procedure: allogeneic hematopoietic stem cell transplantation, Procedure: umbilical cord blood transplantationPatients receive a test dose of busulfan on day -10 and then dose adjusted busulfan IV 3-4 times daily on days -9 to -6, melphalan IV on days -5 and -4, and fludarabine phosphate IV on days -5 to -2. UCB transplantation: Patients receive 2 combined units of UCB IV on day 0. Patients also receive G-CSF IV or subcutaneously beginning on day 5 (or later) and continuing until blood counts recover. GVHD prophylaxis: Patients receive cyclosporine IV twice daily beginning on day -1 followed by a taper according to institutional guidelines. Patients also receive mycophenolate mofetil orally or IV beginning on day 0 and continuing until day 27 (or as clinically indicated). |
| Regimen III (TBI, Cyclophosphamide, Fludarabine) | Experimental | Biological: filgrastim, Drug: Cyclophosphamide, Drug: Cyclosporine, Drug: Fludarabine phosphate, Drug: Mycophenolate Mofetil, Procedure: allogeneic hematopoietic stem cell transplantation, Procedure: umbilical cord blood transplantation, Radiation: total-body irradiationPatients receive fludarabine phosphate IV on days -8 to -4 and cyclophosphamide IV over 2 hours on day -3 and undergo TBI (single dose) on day -2. UCB transplantation: Patients receive 2 combined units of UCB IV on day 0. Patients also receive G-CSF IV or subcutaneously beginning on day 5 (or later) and continuing until blood counts recover. GVHD prophylaxis: Patients receive cyclosporine IV twice daily beginning on day -1 followed by a taper according to institutional guidelines. Patients also receive mycophenolate mofetil orally or IV beginning on day 0 and continuing until day 27 (or as clinically indicated). |
| Regimen IV (Fludarabine, Melphalan) | Experimental | Biological: filgrastim, Drug: Cyclosporine, Drug: Fludarabine phosphate, Drug: Melphalan, Drug: Mycophenolate Mofetil, Procedure: allogeneic hematopoietic stem cell transplantation, Procedure: umbilical cord blood transplantationPatients receive fludarabine phosphate IV on days -7 to -3 and melphalan IV on day -2. UCB transplantation: Patients receive 2 combined units of UCB IV on day 0. Patients also receive G-CSF IV or subcutaneously beginning on day 5 (or later) and continuing until blood counts recover. GVHD prophylaxis: Patients receive cyclosporine IV twice daily beginning on day -1 followed by a taper according to institutional guidelines. Patients also receive mycophenolate mofetil orally or IV beginning on day 0 and continuing until day 27 (or as clinically indicated). |
Who may qualify
- Ages
- 0 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| filgrastim | Biological | Regimen I (FTBI, Cyclophosphamide, Fludarabine), Regimen II (Busulfan, Fludarabine, Melphalan), Regimen III (TBI, Cyclophosphamide, Fludarabine), Regimen IV (Fludarabine, Melphalan) |
| BusulfanAlso: Busilvex | Drug | Regimen II (Busulfan, Fludarabine, Melphalan) |
| CyclophosphamideAlso: CTX | Drug | Regimen I (FTBI, Cyclophosphamide, Fludarabine), Regimen III (TBI, Cyclophosphamide, Fludarabine) |
| CyclosporineAlso: CsA | Drug | Regimen I (FTBI, Cyclophosphamide, Fludarabine), Regimen II (Busulfan, Fludarabine, Melphalan), Regimen III (TBI, Cyclophosphamide, Fludarabine), Regimen IV (Fludarabine, Melphalan) |
| Fludarabine phosphateAlso: Fludara | Drug | Regimen I (FTBI, Cyclophosphamide, Fludarabine), Regimen II (Busulfan, Fludarabine, Melphalan), Regimen III (TBI, Cyclophosphamide, Fludarabine), Regimen IV (Fludarabine, Melphalan) |
| MelphalanAlso: Alkeran | Drug | Regimen II (Busulfan, Fludarabine, Melphalan), Regimen IV (Fludarabine, Melphalan) |
| Mycophenolate MofetilAlso: MMF | Drug | Regimen I (FTBI, Cyclophosphamide, Fludarabine), Regimen II (Busulfan, Fludarabine, Melphalan), Regimen III (TBI, Cyclophosphamide, Fludarabine), Regimen IV (Fludarabine, Melphalan) |
| allogeneic hematopoietic stem cell transplantationAlso: AlloHCT | Procedure or surgery | Regimen I (FTBI, Cyclophosphamide, Fludarabine), Regimen II (Busulfan, Fludarabine, Melphalan), Regimen III (TBI, Cyclophosphamide, Fludarabine), Regimen IV (Fludarabine, Melphalan) |
| umbilical cord blood transplantation | Procedure or surgery | Regimen I (FTBI, Cyclophosphamide, Fludarabine), Regimen II (Busulfan, Fludarabine, Melphalan), Regimen III (TBI, Cyclophosphamide, Fludarabine), Regimen IV (Fludarabine, Melphalan) |
| total-body irradiationAlso: TBI | Radiation | Regimen III (TBI, Cyclophosphamide, Fludarabine) |
| Fractionated total body irradiationAlso: FTBI | Radiation | Regimen I (FTBI, Cyclophosphamide, Fludarabine) |
Primary outcome
Survival Rate at Day 100 After Allogeneic Transplant From Umbilical Cord Blood (UCB)
Time frame: From transplant to Day 100 post-transplant
Number of surviving patients at Day 100 post-transplant divided by number of patients undergone transplantation.
1 secondary outcome
Survival Rate at Day 180 After Allogeneic Transplant From Umbilical Cord Blood (UCB)
Time frame: From transplant up to Day 180 post-transplant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- 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.
Anna Pawlowska, MD principal investigator
City of Hope Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing filgrastim, Busulfan and Cyclophosphamide in people with Leukemia and Lymphoma, run by City of Hope Medical 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?
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 14 Jun 2024. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Apr 2023). 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?
Survival Rate at Day 100 After Allogeneic Transplant From Umbilical Cord Blood (UCB) (time frame: From transplant to Day 100 post-transplant). 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 14 Jun 2024.