RECRUITING

Two Step Haplo With Radiation Conditioning

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Conditions

Acute Lymphoblastic LeukemiaAcute Myeloid LeukemiaAdult T-Cell Leukemia/LymphomaAplastic AnemiaChronic Lymphocytic LeukemiaChronic Myeloid Leukemia, BCR-ABL1 PositiveChronic Myelomonocytic LeukemiaEssential ThrombocythemiaHematopoietic and Lymphatic System NeoplasmHodgkin LymphomaMultiple MyelomaMyelodysplastic SyndromeMyelofibrosisMyeloid NeoplasmNon-Hodgkin LymphomaPolycythemia VeraSmall Lymphocytic Lymphoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase II clinical trial evaluates whether a modified modality of conditioning reduces treatment-related mortality (TRM) in patients who undergo a hematopoietic stem cell transplant (HSCT) for a hematological malignancy. HSCT is a curative therapy for many hematopoietic malignancies, however this regimen results in higher rates of TRM than other forms of treatment. In recent years, less intense conditioning regimens with radiation and chemotherapy prior to HSCT have been developed. Radiation therapy uses high energy sources to kill cancer cells and shrink tumors while chemotherapy drugs like fludarabine and cyclophosphamide work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This study evaluates whether a two-step approach with lower-intensity regimens of these treatments prior to HSCT reduces the rate of TRM.

Official Title

A 2 Step Approach to Haploidentical Transplant Using Radiation-Based Reduced Intensity Conditioning

Quick Facts

Study Start:2021-10-25
Study Completion:2032-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05031897

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Radiation-based cohort diagnoses:
  2. * Acute myeloid leukemia
  3. * Acute lymphoid leukemia in remission
  4. * Myelodysplasia (MDS)
  5. * Chronic lymphocytic leukemia (CLL) with no or minimal lymph node involvement
  6. * Multiple myeloma
  7. * Chronic myeloid leukemia
  8. * Myelofibrosis
  9. * Myeloid malignancy not otherwise specified
  10. * Chronic myelomonocytic leukemia
  11. * Essential thrombocytopenia or polycythemia vera
  12. * T cell leukemia
  13. * T cell lymphoma without significant lymph node disease burden
  14. * Any hematological malignancy or dyscrasia not cited above in which HSCT is potentially curable
  15. * Any patient who has a hematological disease that would normally be treated on a myeloablative study, but is prevented from doing so by factors in their past medical history. Examples are patients with previous treatment with radiation therapy precluding total-body irradiation (TBI), or a past history of myeloablative therapy, precluding a 2nd myeloablative regimen.
  16. * Patients must have a donor who is one-haplotype mismatched (number of mismatches in either direction not considered)
  17. * Chemotherapy-based cohort diagnoses:
  18. * Hodgkin or non-Hodgkin lymphoma
  19. * Small lymphocytic lymphoma/CLL
  20. * Any other diagnosis in which chemotherapy is thought to be superior to radiotherapy for treatment of the disease
  21. * Hematological malignancy in patients who cannot receive \> 2 Gy radiation
  22. * Aplastic anemia and other non-malignant hematologic dyscrasias
  23. * Patients must have a donor who is one-haplotype mismatched (number of mismatches in either direction not considered)
  24. * Human leukocyte antigen (HLA) identical cohort diagnoses:
  25. * Left ventricular ejection fraction of \>= 50%
  26. * Diffusion lung capacity of oxygen \>= 50% and forced expiratory volume at 1 second \>= 50% of predicted corrected for hemoglobin
  27. * Serum bilirubin =\< 1.8
  28. * Aspartate aminotransferase or alanine aminotransferase =\< 2.5 x upper limit of normal
  29. * Creatinine clearance of \>= 60 mL/min
  30. * Patients must have adequate Karnofsky performance status (KPS) and Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) scores:
  31. * Patients \< age 60 years must have a KPS of \>= 60% and an HCT-CI score of 5 or less
  32. * Patients aged 60 to 65 years must have a KPS of \>= 60% and an HCT-CI score of 4 or less
  33. * Patients aged 66 to 69 years must have a KPS of 90% and an HCT-CI score of 3 or less
  34. * Patients aged 70 years or more must have a KPS of 90% and an HCT-CI score of 2 or less
  35. * (Patients with greater than the allowable HCT-CI points for age can be enrolled for trial with approval of the principal investigator (PI) and at least 1 co-investigator (CI) not on the primary care team of the patient). This is an adjustment to account for healthy patients who meet the spirit of this protocol but have histories that result in higher than guideline HCT-CI 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
  36. * Patients must be willing to use contraception if they have childbearing potential
  37. * Patient or patient's guardian is able to give informed consent
  38. * Patients should have a life expectancy of \>= 6 months for reasons other than their underlying hematologic/oncologic disorder
  39. * Patients with evidence of another malignancy, exclusive of a skin cancer that requires only local treatment, should not be enrolled on this protocol
  40. * Patients should not be:
  41. * Human immunodeficiency virus positive
  42. * Have active involvement of the central nervous system with malignancy. This can be documented by a normal neurological exam, magnetic resonance imaging (MRI) of the head, and/or a negative cerebral spinal fluid analysis
  43. * Pregnant or breastfeeding
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Usama Gergis, MD
CONTACT
215-503-2455
usama.gergis@jefferson.edu

Principal Investigator

Usama Gergis, MD
PRINCIPAL_INVESTIGATOR
Thomas Jefferson University

Study Locations (Sites)

Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadephia, Pennsylvania, 19107
United States

Collaborators and Investigators

Sponsor: Thomas Jefferson University

  • Usama Gergis, MD, PRINCIPAL_INVESTIGATOR, Thomas Jefferson University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-25
Study Completion Date2032-04

Study Record Updates

Study Start Date2021-10-25
Study Completion Date2032-04

Terms related to this study

Additional Relevant MeSH Terms

  • Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia
  • Adult T-Cell Leukemia/Lymphoma
  • Aplastic Anemia
  • Chronic Lymphocytic Leukemia
  • Chronic Myeloid Leukemia, BCR-ABL1 Positive
  • Chronic Myelomonocytic Leukemia
  • Essential Thrombocythemia
  • Hematopoietic and Lymphatic System Neoplasm
  • Hodgkin Lymphoma
  • Multiple Myeloma
  • Myelodysplastic Syndrome
  • Myelofibrosis
  • Myeloid Neoplasm
  • Non-Hodgkin Lymphoma
  • Polycythemia Vera
  • Small Lymphocytic Lymphoma