Phase 2 Lymphoma Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People diagnosed with one of the following blood cancers or related conditions, who the trial site doctor considers a suitable candidate for a stem cell transplant from a donor (allogeneic HCT):
  • Acute lymphoblastic leukemia (ALL) with less than 5% abnormal cells in the bone marrow
  • Acute myeloid leukemia (AML) with less than 25% abnormal cells in the bone marrow
  • Other types of acute leukemia or related blood disorders (including several specific subtypes — confirm with trial site) with less than 5% abnormal cells in the bone marrow
  • A bone marrow disorder called myelodysplastic syndrome (MDS) with excess abnormal cells, where the person has already received certain types of chemotherapy
• People aged 6 months to 26 years old at the time consent is signed
• People who have a matching donor — either a family member or an unrelated person — who matches on 8 out of 8 specific genetic markers (HLA type)
• People whose transplant will use stem cells collected from blood or bone marrow (not from umbilical cord blood)
• People with a general health and activity level score of 60% or above on a standard medical scale
• People whose heart is pumping at 40% or more of its normal capacity, as measured by a heart scan
• People whose lungs are working at 60% or more of expected capacity on a breathing test; for children under 6 or those unable to do the breathing test, blood oxygen levels must be 92% or above while breathing normal air
• People whose liver chemical levels (bilirubin, ALT, and AST) are within an acceptable range, or where any higher levels are explained by the disease or medication (confirm with trial site if levels are elevated)
• People whose kidney function is within a normal range for their age, or where a more detailed kidney test shows adequate function
• People whose legally authorised representative, and the patient themselves where appropriate, have given signed consent to participate

Donor requirements (the person donating the stem cells must also meet certain criteria):

• The donor may be a family member or an unrelated person, matched at 8 out of 8 HLA genetic markers
• The donor must be 14 years of age or older
• The donor must be available to donate within the United States
• The donor must agree to donate either bone marrow or blood stem cells, whichever the trial requires
• Unrelated donors must meet eligibility standards set by the National Marrow Donor Program (NMDP), with required testing done in an approved laboratory
• Related donors must test negative for HIV, hepatitis B, hepatitis C, and certain other infections, with testing done in an approved laboratory, and must meet the institution's donor eligibility standards

Who may not be able to join:

• People with active disease affecting the brain or spinal fluid that has not been cleared before the transplant preparation begins (a history of such disease may still be acceptable — confirm with trial site)
• People currently participating in another research study aimed at preventing a transplant complication called graft-versus-host disease (GVHD)
• People who weigh more than 100 kg and have a matched related donor; people who weigh more than 75 kg and have a matched unrelated donor must have their case discussed with the lead trial doctor before enrolling
• People who are HIV-positive
• People with an infection that is not under control, unless an infectious disease specialist and the trial doctors agree the person is suitable to proceed (a simple upper respiratory tract infection does not disqualify someone)
• People whose life expectancy is less than 3 months due to a condition other than the leukemia or MDS being treated
• People with another serious medical condition that would make a stem cell transplant unsafe
• People who have previously had a stem cell transplant, either from a donor or using their own cells
• People who are pregnant or breastfeeding
• People of childbearing potential who are not willing to use effective contraception or abstain from sexual activity during treatment and for 12 months after the transplant
• People with a known allergy or sensitivity to the medications tacrolimus, fludarabine, or methotrexate

Important: Always verify eligibility with the trial site directly before applying.