Phase 3 Lymphoma Trial, Recruiting NCT04314219 Sponsor: King Faisal Specialist Hospital & Research Center Condition: Lymphoma
Back to Lymphoma

Phase 3 Lymphoma Trial, Recruiting

NCT04314219
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People diagnosed with Acute Leukemia (AML or ALL) whose disease has gone into complete remission, with or without full blood count recovery
  • People who have a fully matched related donor (matched at 8 out of 8 markers) who is willing and medically cleared to donate blood stem cells
  • People whose treatment plan includes a high-intensity (myeloablative) conditioning regimen before transplant
  • People whose heart is pumping at 50% or better efficiency, as measured by a cardiac scan
  • People whose kidneys are filtering at a rate greater than 50 mL per minute
  • People whose lungs are functioning at 50% or better on breathing tests (DLCO, FVC, and FEV1)
  • People whose liver function tests are within an acceptable range (bilirubin less than twice the upper limit of normal, and liver enzymes less than 2.5 times the upper limit of normal)
  • People who have signed a consent form agreeing to take part in the trial

Who may not be able to join:

  • People whose general physical functioning score (Karnofsky or Lansky scale) is below 70% — meaning those who have significant difficulty with daily activities
  • People whose leukemia is still active (not in remission)
  • People with an active bacterial, viral, or fungal infection that is not under control
  • People with fluid build-up in the body (such as in the abdomen, lungs, or around the heart) that could interfere with the clearance of a drug called methotrexate
  • People who test positive for HIV-1 or HIV-2
  • People who test positive for HTLV-I or HTLV-II (a type of virus affecting blood cells)
  • People with active Hepatitis B or C virus detected in their blood by a specific laboratory test (PCR)
  • People who are pregnant or currently breastfeeding
  • People of childbearing potential, or men who have sexual contact with people of childbearing potential, who are not willing to use effective contraception or abstinence for one year after transplant
  • People with a history of autoimmune disease that is not well controlled, or who are currently being treated for one
  • People who have had another cancer in the past, unless it was a non-melanoma skin cancer that was removed, cervical cancer treated in its earliest stage, or any cancer treated with the intent to cure at least 5 years ago

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

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 20 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Riad O El Fakih, MD, KFSH&RC

Phone: + 966114647272

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
King Faisal Specialist Hospital & Research Center
Registry
ClinicalTrials.gov
Start date
15 August 2021
Est. completion
1 December 2025

Where this trial is recruiting

🇸🇦 Saudi Arabia

Primary endpoints

GRFS (GVHD-free/relapse-free survival)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov