Status:
COMPLETED
Haploidentical Hematopoietic Stem Cell Transplantation Using A Novel Clofarabine Containing Conditioning Regimen For Patients With Refractory Hematologic Malignancies
Lead Sponsor:
St. Jude Children's Research Hospital
Collaborating Sponsors:
Genzyme, a Sanofi Company
Conditions:
Hematologic Malignancies
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE1
Brief Summary
Patients with refractory hematologic malignancies including those who develop recurrent disease after allogeneic hematopoietic stem cell transplantation (HSCT) have a dismal prognosis. Historically, b...
Detailed Description
The primary objective of this trial is to determine the maximum tolerated dose of clofarabine in combination with thiotepa and melphalan as a conditioning regimen for a haploidentical stem cell transp...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Age less than or equal to 21 years old; may be greater than 21 years old if a previously treated St. Jude patient and within 3 years of completion of most recent prior disease specific therapy.
- One of the following refractory hematologic malignancies (chemoresistant relapse or primary induction failure) or diagnoses:
- ALL
- AML (\>25% blasts in the bone marrow)
- secondary AML/MDS
- CML in accelerated phase or blast crisis
- juvenile myelomonocytic leukemia (JMML)
- myelodysplastic syndrome (MDS)
- Hodgkin or non-Hodgkin lymphoma (NHL) with residual or recurrent disease following autologous HSCT, who are unable to undergo autologous HSCT due to chemo-resistant disease or inability to have an acceptable quantity of tumor-free stem cells collected (\> 1 x 108 TNC/kg marrow or \> 1 x 106 CD34+/kg PBS
- patients with a hematologic malignancy who have undergone prior allogeneic HSCT or who have a co-morbid condition that in the medical opinion of medical faculty (Division of Bone Marrow Transplantation and Cellular Therapy) makes standard myeloablation prohibitive
- Does not have any other active malignancy other than the one for which this transplant is indicated
- Cardiac shortening fraction greater than or equal to 25%
- For pediatric patients, creatinine clearance greater than or equal to 90 ml/min/1.73 m2 according to the Schwartz formula for estimated GFR (ml/min/1.73m2) = k\*height (cm)/serum creatinine (mg/dL). k is a proportionality constant that varies with age and is a function of urinary creatinine clearance per unit of body size; 0.45 up to 12 months of age; 0.55 children and adolescent girls; and 0.70 for adolescent boys
- For adolescent or adult patients, serum creatinine 1.0 mg/dL; if serum creatinine 1.0 mg/dL, then the estimated glomerular filtration rate (GFR) must be 60 mL/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease equation where predicted GFR (ml/min/1.73 m2) = 186 x (serum creatinine)-1.154 x (age in years)-0.023 x (0.742 if patient is female) x (1.212 if patient is black)
- Forced vital capacity (FVC) greater than or equal to 40% of predicted value or pulse oximetry greater than or equal to 92% on room air.
- Karnofsky or Lansky (age-dependent) performance score of greater than or equal to 50 (See APPENDIX A)
- Does not have active acute or active chronic GVHD defined as requiring medical therapy.
- Does not have active acute bronchiolitis obliterans (BO) or bronchiolitis obliterans organizing pneumonia (BOOP).
- Has a suitable HLA partially matched family member donor available for stem cell donation
- Bilirubin less than or equal to 1.5 times the upper limit of normal for age.
- Alanine aminotransferase (ALT) less than or equal to 1.5 times the upper limit of normal for age.
- Aspartate aminotransferase (AST) less than or equal to 1.5 times the upper limit of normal for age.
- Not pregnant (confirmed by negative serum or urine pregnancy test within 14 days prior to enrollment).
- Not lactating
- Inclusion criteria (stem cell donor):
- Partially HLA-matched family member.
- At least 18 years of age.
- HIV negative
- Not pregnant (confirmed by negative serum or urine pregnancy test within 14 days prior to enrollment).
- Not lactating
Exclusion
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00824135
Start Date
January 1 2009
End Date
December 1 2016
Last Update
January 2 2017
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38119