World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 11 January 2021
Main ID:  NCT02566304
Date of registration: 30/09/2015
Prospective Registration: Yes
Primary sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
Public title: Reduced Intensity Chemotherapy and Radiation Therapy Before Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies
Scientific title: A Two Step Approach to Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Hematologic Malignancies
Date of first enrolment: November 13, 2015
Target sample size: 30
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT02566304
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Name:     Dolores Grosso, DNP, CRNP
Address: 
Telephone: 215-955-8874
Email:
Affiliation: 
Name:     Dolores Grosso, DNP, CRNP
Address: 
Telephone: 215-955-8874
Email:
Affiliation: 
Name:     Dolores Grosso, DNP, CRNP
Address: 
Telephone:
Email:
Affiliation:  Thomas Jefferson University
Name:     Neal Flomenberg, MD
Address: 
Telephone:
Email:
Affiliation:  Thomas Jefferson University
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Patients treated on this study will have:

1. Acute myeloid leukemia in morphologic CR not requiring treatment for their
disease for 6 weeks

2. A history of AML with < 20% residual blasts after induction therapy and
persisting with <20% blasts for at least 8 weeks without reinduction.

3. RA or RARS or isolated 5q- can proceed to transplant without any treatment

4. RAEB-1, RCMD+/-RS, or MDS NOS with stable disease for 6 months (as documented by
serial bone marrow examinations) in the absence of any therapy but growth factors
or transfusion support. Patients who require treatment to "control their disease"
must show chemo-responsiveness

5. CMML or RAEB-2 must demonstrate chemo-responsiveness. Chemo-responsiveness is
defined as a blast percentage decrease by at least 5 percentage points and there
must be less than 20% blasts after treatment and at the time of transplant

6. Hodgkin or Indolent Non-Hodgkin's lymphoma

7. Myeloma with < 5% plasma cells in the marrow

8. Myeloproliferative disorders

9. Aplastic Anemia

10. A hematological or oncological disease (not listed) in which allogeneic HSCT is
thought to be beneficial, and the disease is chemoresponsive.

11. Patients without clear manifestation of their disease status in terms of stage
and/or responsiveness should be discussed with the PI and enrollment analysis
should be documented in the study records.

2. Patients must have a related donor who is HLA mismatched at 2, 3, or 4 antigens at the
HLA-A; B; C; DR loci in the GVHD direction. (Patients with related donors who are HLA
identical or are a 1-antigen mismatch may be treated on this therapeutic approach, but
will have their outcomes will not be part of the statistical aims of the study (see
Statistical Section). The HLA matched related category includes patients with a
syngeneic donor.

3. Patients must have had front line therapy for their disease.

4. Patients must adequate organ function:

1. LVEF (Left ventricular end diastolic function) of >/=45%.

2. DLCO (Diffusing Capacity of the Lung for Carbon Monoxide ) =45% of predicted
corrected for hemoglobin, FEV-1 (forced expiratory volume at 1 second =50% of
predicted

3. Adequate liver function as defined by a serum bilirubin <1.8, AST or ALT < 2.5X
upper limit of normal

4. Creatinine Clearance of = 60 mL/min

5. HCT-CI/Age Score = 5 points (Patients with greater than 5 points will be allowed for
trial with approval of the PI and the Co-PI or his designee. This is an adjustment to
account for healthy patients who meet the spirit of this protocol but have histories
that result in higher than HCT-CI 5 points. An example is a patient with a solid tumor
malignancy in their remote history (adds 3 points to HCT-CI total) where the treatment
for the malignancy occurred years to decades before and there has been complete
recovery of toxicities.

6. KPS= 90% patients older than 70 years, KPS= 80% patients younger than 70 years

7. Patients must be willing to use contraception if they have childbearing potential

Exclusion Criteria:

1. Performance status < 90% in patients 70 years old or greater, <80% in patients less
than age 70 years

2. HCT-CI/age Score >5 points (Patients with greater than 5 points will be allowed for
trial with approval of the Principal Investigator and the Co-Principal Investigator or
his designee. This is an adjustment to account for healthy patients who meet the
spirit of this protocol but have histories that result in higher than HCT-CI 5 points.
An example is a patient with a solid tumor malignancy in their remote history (adds 3
points to HCT-CI total) where the treatment for the malignancy occurred years to
decades before and there has been complete recovery of toxicities.

3. A diagnosis of CMML, unless in morphologic CR

4. HIV positive

5. Active involvement of the central nervous system with malignancy

6. Inability to obtain informed consent from patient or surrogate

7. Pregnancy

8. Patients with life expectancy of < 6 months for reasons other than their underlying
hematologic/oncologic disorder

9. Patients who have received alemtuzumab or antithymocyte globulin within 8 weeks of the
transplant admission. The absence of these therapies in the medical record will serve
as documentation that they were not given.

10. Patients with evidence of another malignancy, exclusive of a skin cancer that requires
only local treatment, should not be enrolled on this protocol



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Acute Myeloid Leukemia
Acute Myeloid Leukemia in Remission
Aplastic Anemia
Chronic Myelomonocytic Leukemia
Hodgkin Lymphoma
Indolent Non-Hodgkin Lymphoma
Malignant Neoplasm
Myelodysplastic Syndrome
Myeloproliferative Neoplasm
Plasma Cell Myeloma
Refractory Anemia
Refractory Anemia With Excess Blasts
Refractory Anemia With Ring Sideroblasts
Refractory Cytopenia With Multilineage Dysplasia
Refractory Cytopenia With Multilineage Dysplasia and Ring Sideroblasts
Intervention(s)
Biological: T Cell-Depleted Donor Lymphocyte Infusion
Drug: Cyclophosphamide
Drug: Fludarabine
Drug: Mycophenolate mofetil
Drug: Tacrolimus
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Procedure: Peripheral Blood Stem Cell Transplantation
Radiation: Total-Body Irradiation
Primary Outcome(s)
Overall Survival (OS) [Time Frame: At 1 year post HSCT]
Secondary Outcome(s)
Engraftment rates [Time Frame: Up to 1 year post HSCT]
Incidence and severity of GVHD [Time Frame: Up to 1 year post HSCT]
Lymphoid reconstitution [Time Frame: Up to 1 year post HSCT]
Non-Relapse Mortality (NRM) [Time Frame: At 1 year post HSCT]
Relapse Related Mortality (RRM) [Time Frame: At 1 year post HSCT]
Secondary ID(s)
15D.323
2015-054
NCI-2015-01506
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history