An Early Phase 1 interventional study of Stem cell transplantation in Hodgkin Lymphoma, Lymphocytic Leukemia and Mixed Cell Leukemia, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged 4 Years to 20 Years. Per ClinicalTrials.gov, last updated 2019-12-16.
Sponsored by National Cancer Institute (NCI) · Early Phase 1, Interventional, and Treatment
Background:
Objectives:
The primary objective of this protocol is to evaluate the efficacy and safety of this treatment approach in pediatric patients with hematopoietic malignancies
Eligibility:
Inclusion Criteria
Age: Patient must be greater than or equal to 5 years and less than 22 years of age.
Diagnosis:
Prior Therapy: Chemotherapy to achieve above criteria allowed. Prior BMT allowed as long as at least day 100+ post-prior BMT, no evidence of GVHD, and no detectable residual donor chimerism.
Donor: First degree related donors, who are HLA matched (single HLA-A or B locus mismatch allowed), weight greater than or equal to 15 kilograms, and who meet standard donation criteria will be considered. The same donor from a prior BMT is allowed.
ECOG Performance Status: 0, 1, or 2. and life expectancy: greater than 3 months.
Liver Function: Serum direct bilirubin less than 2.0 mg/dL and serum ALT and AST values less than or equal to 2.5x upper limit of normal. (Values above these levels may be accepted if due to malignancy.)
Renal Function: Age adjusted normal serum creatinine or Cr clearance greater than or equal to 60 mL/min/1.73 m(2).
Pulmonary Function: DLCO greater than or equal to 50%.
Cardiac Function: LVEF greater than or equal to 45% by MUGA or LVSF greater than or equal to 28% by ECHO
Exclusion Criteria
Design:
Pilot Study
Background:
Objectives:
The primary objective of this protocol is to evaluate the efficacy and safety of this treatment approach in pediatric patients with hematopoietic malignancies
Eligibility:
Inclusion Criteria
Age: Patient must be greater than or equal to 5 years and less than 22 years of age.
Diagnosis:
Prior Therapy: Chemotherapy to achieve above criteria allowed. Prior BMT allowed as long as at least day 100+ post-prior BMT, no evidence of GVHD, and no detectable residual donor chimerism.
Donor: First degree related donors, who are HLA matched (single HLA-A or B locus mismatch allowed), weight greater than or equal to 15 kilograms, and who meet standard donation criteria will be considered. The same donor from a prior BMT is allowed.
ECOG Performance Status: 0, 1, or 2. and life expectancy: greater than 3 months.
Liver Function: Serum direct bilirubin less than 2.0 mg/dL and serum ALT and AST values less than or equal to 2.5x upper limit of normal. (Values above these levels may be accepted if due to malignancy.)
Renal Function: Age adjusted normal serum creatinine or Cr clearance greater than or equal to 60 mL/min/1.73 m(2).
Pulmonary Function: DLCO greater than or equal to 50%.
Cardiac Function: LVEF greater than or equal to 45% by MUGA or LVSF greater than or equal to 28% by ECHO
Exclusion Criteria
Design:
Pilot Study
914 studies on the registry are indexed under Hodgkin Disease; 136 are open to participants now.
This study's enrollment of 30 is below the median of 43 across 746 interventional studies indexed under Hodgkin Disease.
Browse Hodgkin Disease studies →National Cancer Institute (NCI) is the lead sponsor of 3,554 studies on the registry; 334 are open to participants now.
Of its 407 completed or terminated interventional studies of FDA-regulated products, 370 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with the following diagnoses will be considered:
Patients must be greater than or equal to 4 years and less than 22 years of age.
Prior chemotherapy: Chemotherapy to achieve above noted criteria allowed. Prior autologous BMT allowed. Prior allogeneic BMT allowed as long as at least day +100 post-prior BMT, and no evidence of ongoing active GVHD.
Availability of 5 or 6 antigen genotypic HLA-matched first-degree relative donor (single HLA-A or B locus mismatch allowed).
Performance status of 0,1, or 2.
Life expectancy greater than 3 months.
Liver function: serum direct bilirubin less than 2.0 mg/dL, and serum ALT and AST values less than or equal to 2.5 times the upper limit of normal. Values above these levels may be accepted, at the discretion of the PI, if such elevations are thought to be due to malignancy (excluding acute leukemia).
Renal function: age-adjusted normal serum creatinine or a creatinine clearance greater than or equal to 60 mL/min/1.73 m(2).
Pulmonary function: DLCO corrected for hemoglobin and alveolar volume greater than or equal to 50% of predicted.
Left ventricular function: Ejection fraction greater than or equal to 45% by MUGA or shortening fraction greater than or equal to 28% by ECHO.
Ability to give informed consent. For patients less than 18 years old their legal guardian must give informed consent. Pediatric patients will be included in age appropriate discussion in order to obtain verbal assent.
Durable power of attorney form completed (patients greater than 18 years of age only).
Patients must not have an active CNS malignancy as defined by: lymphoma (tumor mass on CT scan or leptomeningeal disease), Leukemia (CNS 2 or CNS 3 classification), or NB (History of CNS involvement with no current evidence of CNS malignancy is NOT an exclusion).
Patients must not be HIV positive.
Patients must not have active hepatitis B or C infection as defined by seropositive for hepatitis B (HbSAg) or hepatitis C and elevated liver transaminases.
Female patients must not be lactating or pregnant (due to risk to fetus or newborn).
Patients must not have high risk of inability to comply with transplant protocol as determined by principal investigator, social work, and BMT team.
Patients must not have Fanconi Anemia (FA): patients with MDS must have a negative FA test.
INCLUSION CRITERIA DONOR:
First degree relative with genotypic identity at 5 or 6 HLA loci (single HLA-A or B locus mismatch allowed).
Weight of greater than or equal to 15 kilograms.
Adequate venous access for peripheral apheresis, or consent to use a temporary central venous catheter for apheresis (on Cohort #2, for possible future cell collection if needed).
Ability to give informed consent. For donors less than 18 years of age, he/she must be the oldest eligible donor, their legal guardian must give informed consent, the donor must give verbal assent, and he/she must be cleared by social work and a mental health specialist to participate.
Donor selection criteria will be in accordance with NIH/CC Department of Transfusion Medicine standards.
EXLCUSION CRITERIA PATIENT:
Active CNS malignancy as defined by:
HIV positive.
Active hepatitis B or C infection as defined by seropositive for hepatitis B (HbsAg) or hepatitis C and elevated liver transaminases.
Lactating or pregnant females.
High risk of inability to comply with transplant protocol as determined by principal investigator, social work, and BMT team.
Fanconi Anemia (FA): Patients with MDS must have a negative FA test.
EXCLUSION CRITERIA DONOR:
History of medical illness which in the estimation of the PI or DTM physician poses prohibitive risk to donation including, but not limited to stroke, hypertension that is not controlled by medication, or heart disease. Individuals with symptomatic angina or a history of coronary artery bypass grafting or angioplasty will not be eligible. History of congenital hematologic, immunologic, or metabolic disorder which in the estimation of the PI poses prohibitive risk to the recipient.
Anemia (Hb less than gm/dl) or thrombocytopenia (less than 100,000/ul).
Lactating or pregnant females.
HIV positive.
Seropositive for hepatitis B (HbsAg) or hepatitis C.
High risk of inability to comply with transplant protocol as determined by principal investigator, social work, and BMT team.
Transplant with Induction Therapy
Procedure: Stem cell transplantation
\>3 x 106/kg CD34+ stem cells by IV infusion
To determine the efficacy and safety of this chemotherapy regimen in facilitating donor engraftment after allogeneic bone marrow transplantation (BMT).
Safety/Efficacy
Time frame: 5 years
Toxicity of regimen
Time frame: 5 years
To determine the toxicity of this non-myelablative allogeneic BMT regimen.
fludarabine-based induction reducing T-cells
Time frame: 5 years
immune suppression
Time frame: 5 years
IL-7 levels
Time frame: 5 years
cytokine profiles
Time frame: 5 years
response rates and DFS
Time frame: 5 years
incidence and severity of GVHD
Time frame: 5 years
response rates, DFS rates, and incidence and severity ofGVHD following withdrawal of immunosuppression and donorlymphocyte infusions (DLI) for patients who developprogressive disease after day +28 post-transplant
Time frame: 5 years
This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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