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NCT00739141

Conditioning Regimen and the Transplantation of Unrelated Donor Umbilical Cord Blood in Patients With Hematologic Malignancies.

Completed Phase 2 Results posted Last updated 8 December 2022
What this trial tests

Phase 2 trial testing fludarabine, cyclophosphamide, thiotepa, radiation therapy, unrelated donor umbilical cord blood graft in Leukemia in 86 participants. Completed in 15 October 2021.

Timeline
12 August 2008
Primary endpoint
15 October 2021
15 October 2021

Quick facts

Lead sponsorMemorial Sloan Kettering Cancer Center
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment86
Start date12 August 2008
Primary completion15 October 2021
Estimated completion15 October 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Memorial Sloan Kettering Cancer Center — full company profile →

Who can join

Adults 18 to 70, any sex, with Leukemia or Myelodysplastic Syndrome. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Progression Free Survival/PFS at 1 Year Post UCBT. Primary · 1 year post UCBT

To obtain a preliminary estimate of progression free survival at 1 year post UCBT. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

GroupValue95% CI
Participants With Hematologic Malignancies8477 – 92
Number of Participants With Neutrophil Recovery Post Allograft for Haplo-dCBT Recipients Secondary · up to 13 days from engraftment

Successful primary donor engraftment = neutrophill recovery within the first 45 days after transplant and partial/complete donor chimerism (\>/= 10%)

Haplo-dCBT with early haplo-derived myeloid bridge
GroupValue95% CI
Participants With Hematologic Malignancies17
Haplo-dCBT with transient haplo-derived bridge with second neutrophil nadir
GroupValue95% CI
Participants With Hematologic Malignancies13
Haplo-dCBT with no bridge
GroupValue95% CI
Participants With Hematologic Malignancies13
Remaining dCBT recipient
GroupValue95% CI
Participants With Hematologic Malignancies43
Percentage of Participants With Sustained CB-derived Neutrophil Engraftment Secondary · 100 days

The day 100 cumulative incidence of sustained CB-derived neutrophil engraftment.

GroupValue95% CI
Participants With Hematologic Malignancies9987 – 99
Percentage of Participants With Sustained CB-derived Platelet Engraftment Secondary · 100 days

The day 100 cumulative incidence of sustained CB-derived platelet engraftment to \>/= 20 x 10\^9/L

GroupValue95% CI
Participants With Hematologic Malignancies9385 – 97

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 3 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Participants With Hematologic Malignancies
Serious: 41/86 (48%)
Deaths: 36/86

Serious adverse events (36 terms)

ReactionSystemParticipants With Hematolo…
Death not assoc w CTCAE term- Death NOSGeneral disorders
Infection, otherInfections and infestations
DiarrheaGastrointestinal disorders
HypoxiaRespiratory, thoracic and mediastinal disorders
Death not assoc w CTCAE term-Disease prog NOSGeneral disorders
Death not assoc w CTCAE term- Multi-organ failureGeneral disorders
Pulm/upp respiratory - Other (spec)Respiratory, thoracic and mediastinal disorders
VomitingGastrointestinal disorders
AnorexiaMetabolism and nutrition disorders
Fever (in the absence of neutropenia)General disorders
HemolysisBlood and lymphatic system disorders
HypotensionVascular disorders
NauseaGastrointestinal disorders
Renal/Genitourinary-Other SpecifyRenal and urinary disorders
Thrombosis/thrombus/embolismVascular disorders
AspirationRespiratory, thoracic and mediastinal disorders
Blood/Bone Marrow, otherBlood and lymphatic system disorders
CreatinineInvestigations
Death not assoc w CTCAE term- Sudden deathGeneral disorders
Dermatology/Skin, otherSkin and subcutaneous tissue disorders
Dyspnea (shortness of breath)Respiratory, thoracic and mediastinal disorders
EncephalopathyNervous system disorders
Extremity-upper (function)Musculoskeletal and connective tissue disorders
Gastrointestinal, otherGastrointestinal disorders
HemoglobinInvestigations
Other adverse events (7 terms — click to expand)

ReactionSystemParticipants With Hematolo…
Glucose, high (hyperglycemia)Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)Investigations
Magnesium, high (hypermagnesemia)Metabolism and nutrition disorders
ALT, SGPTInvestigations
AST, SGOTInvestigations
CreatinineInvestigations
Alkaline phosphataseInvestigations

Most-reported serious reactions: Death not assoc w CTCAE term- Death NOS, Infection, other, Diarrhea, Hypoxia, Death not assoc w CTCAE term-Disease prog NOS, Death not assoc w CTCAE term- Multi-organ failure, Pulm/upp respiratory - Other (spec), Vomiting.

Data from ClinicalTrials.gov NCT00739141 adverse events section.

Sponsor's own description

The traditional way of doing a donor transplant is to give high doses of chemotherapy and radiation before giving the stem cells. However, high doses of chemotherapy and radiation can have serious side-effects. The doctors think that the transplant will be safer and more likely to be successful with reduced doses of chemotherapy and radiation. The purpose of this study is to find out how good a combination of chemotherapy and radiation at reduced doses followed by a cord blood transplant are at treating cancer. The stem cells chosen for the transplant are from umbilical cord blood. Umbilical cord blood is collected from healthy newborn babies and frozen. One cord blood collection is called a "cord blood unit." On transplant day, the cord blood will be given through the catheter just like a blood transfusion. Transplants done this way have been successful. However, this type of transplant is fairly new. Therefore, it is important to study it so the doctors can better understand how it works. Most blood or bone marrow transplants using donor stem cells are done as part of a study. When patients are on a study we test new ways of treating them which we think may be better than the old ways. We collect information about the result of this treatment so we can understand how well the treatment works. This is so we can learn better ways to treat our patients.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Influence of infused cell dose and HLA match on engraftment after double-unit cord blood allografts.
    Avery S, Shi W, Lubin M, Gonzales AM, et al · · 2011 · cited 99× · PMID 21149633 · DOI 10.1182/blood-2010-08-300491
  2. A novel reduced-intensity conditioning regimen induces a high incidence of sustained donor-derived neutrophil and platelet engraftment after double-unit cord blood transplantation.
    Ponce DM, Sauter C, Devlin S, Lubin M, et al · · 2013 · cited 54× · PMID 23416850 · DOI 10.1016/j.bbmt.2013.02.007
  3. High Disease-Free Survival with Enhanced Protection against Relapse after Double-Unit Cord Blood Transplantation When Compared with T Cell-Depleted Unrelated Donor Transplantation in Patients with Acute Leukemia and Chronic Myelogenous Leukemia.
    Ponce DM, Hilden P, Devlin SM, Maloy M, et al · · 2015 · cited 40× · PMID 26238810 · DOI 10.1016/j.bbmt.2015.07.029
  4. Robust CD4+ T-cell recovery in adults transplanted with cord blood and no antithymocyte globulin.
    Politikos I, Lavery JA, Hilden P, Cho C, et al · · 2020 · cited 39× · PMID 31935291 · DOI 10.1182/bloodadvances.2019000836
  5. High progression-free survival after intermediate intensity double unit cord blood transplantation in adults.
    Barker JN, Devlin SM, Naputo KA, Skinner K, et al · · 2020 · cited 35× · PMID 33290545 · DOI 10.1182/bloodadvances.2020003371
  6. Reduced-intensity conditioning hematopoietic stem cell transplantation for chronic lymphocytic leukemia and Richter's transformation.
    Lahoud OB, Devlin SM, Maloy MA, Roeker LE, et al · · 2021 · cited 21× · PMID 34297048 · DOI 10.1182/bloodadvances.2020003726

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