Hematologic MalignanciesPhase 2NCT06807606
Optimized Cord Blood Transplantation for the Treatment of Patients With High-risk Hematologic Malignancies Who Have Relapsed After First Allogeneic Stem Cell Transplantation
A Phase 2 study testing Drugs Cyclophosphamide, Fludarabine and Thiotepa in people with Hematologic Malignancies, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if intermediate-intensity conditioning therapy followed by a cord blood transplant can help to control high-risk hematological malignancies in patients who need a second allogeneic stem cell transplantation. Read more about this study
- Who is it for?
- Ages Up to 60 years
- Conditions the study is for
- Hematologic Malignancies
- What is being tested?
- Drugs Cyclophosphamide, Fludarabine and Thiotepa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2025to 30 Nov 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient aged 0-60 y/o at the time of consent. Adult is defined as patients 18 years of age or older at the time of consent.
- Patient must have relapsed >100 days since first transplant.
- Diagnosis and Disease Status:
- Acute myelogenous leukemia (AML): i. Patients in morphologic remission (<5% blasts) at the time of transplant, with or without persistent cytogenetic, flow cytometric, or molecular aberrations, or those with hypocellular marrows at time of transplant, are eligible. b. Acute lymphoblastic leukemia (ALL): i. Patients in morphologic remission with less than 5% blasts at time of transplant, with or without persistent cytogenetic, flow cytometric or molecular aberrations, or those or who have hypocellular bone marrows, are eligible. c. Other acute leukemias: i. Acute leukemias of ambiguous lineage or mixed phenotype in morphologic remission with less than 5% blasts at time of transplant, with or without persistent cytogenetic, flow cytometric or molecular aberrations, or those who have hypocellular bone marrows, are eligible. d. Myelodysplastic Syndromes (MDS) or CMML without myelofibrosis. i. Includes MDS with any IPSS risk category.
- Prior treatment:
- To be eligible for this study, patients need to have received one prior allogeneic stem cell transplantation.
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- Karnofsky score equal or greater than 70% for patients aged 16 years and older or Lansky score equal or greater than 70% for patients less than 16 years old (See Appendix B; inpatient Leukemia service transfers without discharge are acceptable provided patient has equivalent KPS as if were outpatient).
- Renal and Liver function:
- Calculated creatinine clearance > 50 ml/min.
- Bilirubin < 2 mg/dL (unless benign congenital hyperbilirubinemia or hemolysis).
- ALT < 5 x upper limit of normal (ULN).
- Pulmonary function: Spirometry corrected DLCO ≥ 60% predicted. This criteria is waived for patients who are developmentally unable to complete pulmonary function test.
- Left ventricular ejection fraction (MOD-bp) > 50%.
- Graft Criteria:
- Two CB units will be selected according to the current MDACC CB unit selection algorithm.
- High resolution 8-allele HLA typing and recipient HLA antibody profile will be performed.
- Unit selection will occur based on HLA-match, total nucleated cell (TNC), and CD34+ cell dose adjusted per patient body weight.
- The bank of origin will also be considered.
- Donor-specific HLA antibodies, if present, will also be taken into consideration.
- Each CB unit must be at least 3/8 HLA-matched to the patient considering high-resolution 8-allele HLA typing.
- Each CB unit will be required to have a cryopreserved TNC dose of at least 1.5 x 107 TNC/ recipient body weight (TNC/ kg).
- Each CB unit will be required to have a cryopreserved CD34+ cell dose of at least 1.0 x 105 CD34+ cells/ recipient body weight (CD34+ cells/kg).
- A minimum of one unit will be reserved as a backup graft.
- Each CB unit will be required to be cryopreserved in standard cryovolume. (24- 27 ml/s per unit) and be red blood cell depleted.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
Warren Fingrut, MD, 713-745-2214, wbfingrut@mdanderson.org
Warren Fingrut, MD
About this study
Official title: Optimized CBT for Pts With High-risk Hematologic Malignancies Who Have Relapsed After First ASCT
The goal of this clinical research study is to learn if intermediate-intensity conditioning therapy followed by a cord blood transplant can help to control high-risk hematological malignancies in patients who need a second allogeneic stem cell transplantation.
Read the detailed description
Primary Objective:
To evaluate 1-year overall survival (OS) following CBT with intermediate dose intensity conditioning for patients in need of a second allogeneic stem cell transplantation.
Secondary Objectives:
Speed and success of neutrophil and platelet engraftment. Incidences of graft failure.
- Incidence of day 100 grade II-IV and III-IV aGVHD and day 180 grades II-IV and III-IV aGVHD.
Incidence of 1-year, 2-year, and 3-year cGVHD.
Incidence of TRM (100 days, 6 months, 1 and 2 years).
The probabilities of relapse, OS, PFS, and GRFS at 1 year, 2, and 3 years as listed in the secondary endpoints in section 2.2.
Correlative laboratory studies investigating graft versus leukemia biology.
- Conditions
- Hematologic Malignancies
- Being tested
- Drugs Cyclophosphamide, Fludarabine, Thiotepa, Tacrolimus, Mycophenolate mofetil
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drugs CyclophosphamideDrug
Given as standard of care treatment through IV infusion
FludarabineDrug
Given as standard of care treatment through IV infusion
ThiotepaDrug
Given as standard of care treatment through IV infusion
TacrolimusDrug
Given as standard of care treatment through IV infusion
Given as standard of care treatment through IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Optimized CBT | Experimental | Participants enrollment on trial will be determined by consultation with the physicians of the SCT Service. Receives: Drug: Drugs Cyclophosphamide; Drug: Fludarabine; Drug: Thiotepa; Drug: Tacrolimus; Drug: Mycophenolate mofetil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start3 Mar 2025
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignanciesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Warren Fingrut, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06807606
- Sponsor's protocol ID
- 2024-1605
- Other IDs
- NCI-2025-00794
- Status last verified
- Apr 2026
- First submitted
- 29 Jan 2025
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimized CBT for Pts With High-risk Hematologic Malignancies Who Have Relapsed After First ASCT
- ClinicalTrials.gov ID
- NCT06807606
- Acronym / sponsor ID
- 2024-1605
- Conditions
- Hematologic Malignancies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2029 (estimated)
- First posted
- 4 Feb 2025 (actual)
- 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 goal of this clinical research study is to learn if intermediate-intensity conditioning therapy followed by a cord blood transplant can help to control high-risk hematological malignancies in patients who need a second allogeneic stem cell transplantation.
Detailed description
Primary Objective:
To evaluate 1-year overall survival (OS) following CBT with intermediate dose intensity conditioning for patients in need of a second allogeneic stem cell transplantation.
Secondary Objectives:
Speed and success of neutrophil and platelet engraftment. Incidences of graft failure.
- Incidence of day 100 grade II-IV and III-IV aGVHD and day 180 grades II-IV and III-IV aGVHD.
Incidence of 1-year, 2-year, and 3-year cGVHD.
Incidence of TRM (100 days, 6 months, 1 and 2 years).
The probabilities of relapse, OS, PFS, and GRFS at 1 year, 2, and 3 years as listed in the secondary endpoints in section 2.2.
Correlative laboratory studies investigating graft versus leukemia biology.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Optimized CBT | Experimental | Drug: Drugs Cyclophosphamide, Drug: Fludarabine, Drug: Thiotepa, Drug: Tacrolimus, Drug: Mycophenolate mofetilParticipants enrollment on trial will be determined by consultation with the physicians of the SCT Service. |
Who may qualify
- Ages
- Up to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (24 listed)
- Patient aged 0-60 y/o at the time of consent. Adult is defined as patients 18 years of age or older at the time of consent.
- Patient must have relapsed >100 days since first transplant.
- Diagnosis and Disease Status:
- Prior treatment:
- Karnofsky score equal or greater than 70% for patients aged 16 years and older or Lansky score equal or greater than 70% for patients less than 16 years old (See Appendix B; inpatient Leukemia service transfers without discharge are acceptable provided patient has equivalent KPS as if were outpatient).
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Drugs CyclophosphamideGiven as standard of care treatment through IV infusion | Drug | Optimized CBT |
| FludarabineGiven as standard of care treatment through IV infusion | Drug | Optimized CBT |
| ThiotepaGiven as standard of care treatment through IV infusion | Drug | Optimized CBT |
| TacrolimusGiven as standard of care treatment through IV infusion | Drug | Optimized CBT |
| Mycophenolate mofetilGiven as standard of care treatment through IV infusion | Drug | Optimized CBT |
Primary outcome
Safety and Adverse Events (AEs)
Time frame: Through study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- 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.
Warren Fingrut, MD principal investigator
M.D. 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 Phase 2 study testing Drugs Cyclophosphamide, Fludarabine and Thiotepa in people with Hematologic Malignancies, 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 24 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 28 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Warren Fingrut, MD (713-745-2214, wbfingrut@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year.). 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 28 Apr 2026.