Phase 3 Lymphoma Trial, Completed NCT00412360 Sponsor: Medical College of Wisconsin Condition: Lymphoma
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Trial results

AI generated results 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

According to the results reported on ClinicalTrials.gov, this trial enrolled 224 people in total — 113 in the single umbilical cord blood (UCB) transplant group and 111 in the double UCB transplant group. The trial was comparing two approaches to stem cell transplantation using donated umbilical cord blood: giving patients one cord blood unit versus two. It tracked a range of outcomes including survival, whether the new blood cells successfully established themselves in the body (called "engraftment"), and whether participants developed a condition called graft-versus-host disease (GVHD), where donated cells can react against the recipient's body. The reported data shows that, for overall survival, 73% of participants in the single transplant group and 65% in the double transplant group were alive at the time of reporting. For survival without their original disease returning, the figures were 70% (single) and 64% (double). Regarding engraftment of white blood cells (neutrophils), 89% of the single group and 88% of the double group reached that milestone, taking a reported median (middle value) of 21 days and 23 days respectively. Platelet engraftment was reported in 76% of the single group and 65% of the double group, taking a median of 58 days and 84 days. For graft-versus-host disease, the reported data shows that around 57% (single) and 56% (double) of participants developed any grade of acute GVHD, with more severe acute GVHD (grades III–IV) reported in 13% of the single group and 23% of the double group. Chronic GVHD of any type was reported in 30% (single) and 32% (double) of participants, with the more extensive form seen in 9% and 15% respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 3 Lymphoma Trial, Completed

NCT00412360
Completed Phase 3 🇦🇺 Australian site

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:

  • Two partially matched umbilical cord blood (UCB) units must be available for you that meet specific tissue-matching (HLA) requirements and contain enough cells for transplant (confirm with trial site for exact details)
  • You have a type of blood cancer called acute myeloid leukemia (AML) at certain stages, including high-risk first remission, second or later remission, first relapse with a low level of cancer cells, or remission with incomplete blood count recovery
  • You have AML that was caused by previous cancer treatment, and your prior cancer has been in remission for at least 12 months
  • You have acute lymphocytic leukemia (ALL) at certain high-risk stages in first or second remission, or any third or later remission (confirm with trial site for your specific situation)
  • You have a rare type called NK cell lymphoblastic leukemia in any remission
  • You have biphenotypic or undifferentiated leukemia in any remission, or in first relapse with low levels of cancer cells in the bone marrow
  • You have a bone marrow condition called myelodysplastic syndrome (MDS) at any stage
  • You have chronic myelogenous leukemia (CML) in the chronic or accelerated phase
  • If you have leukemia affecting the brain or spinal fluid, it must have been treated and be in remission
  • If you are 16 or older, you must be reasonably active and able to carry out normal daily activities (scored at least 70% on a standard health scale); if you are under 16, a similar age-appropriate scale applies
  • Your heart, liver, kidneys, and lungs must be functioning well enough to meet specific medical thresholds (confirm with trial site for exact measurements)

Who may not be able to join:

  • You are pregnant or breastfeeding
  • You have HIV infection or test positive for HIV
  • You currently have an uncontrolled bacterial, viral, or fungal infection that is getting worse despite treatment
  • You had an autologous (your own cells) stem cell transplant less than 12 months before enrolling
  • You previously had an autologous transplant for the same disease being treated in this trial
  • You have previously had an allogeneic (donor cells) stem cell transplant
  • You have another active cancer (other than the one being treated here) within 12 months of enrolling
  • You are unable to receive total body radiation (TBI), which is part of the treatment
  • You currently need extra oxygen to breathe
  • You have a fully tissue-matched (HLA-matched) related family member who is able to donate stem cells

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 13 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: Mary Horowitz, MD, MS, Center for International Blood and Marrow Transplant Research

Australian sites

Children's Hospital at Westmead, Westmead, New South Wales

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
Completed
Phase
Phase 3
Sponsor
Medical College of Wisconsin
Registry
ClinicalTrials.gov
Start date
1 December 2006
Est. completion
1 March 2014

Where this trial is recruiting

🇦🇺 Australia 🇨🇦 Canada 🇺🇸 United States

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Percentage of Participants With Overall 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: 13 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