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New stem cell transplant shows promise for kids with tough cancers

NCT ID NCT01625351

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new way to do stem cell transplants in 23 children with cancers that came back or didn't respond to treatment. The method removes certain immune cells from the donor's stem cells to help the child's body recover faster and fight infections better. The goal was to see if the transplant was safe and possible, and to track survival and recovery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
stem cell transplant with selective T-cell depletion
What this could lead to
If successful, this approach could make stem cell transplants safer and more effective for children with hard-to-treat cancers, potentially improving survival rates.
What could go wrong
This is an early phase I trial with only 23 participants, so results may not apply broadly. Risks include infection, graft failure, and side effects from chemotherapy and immune-suppressing drugs.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

23 people

The number who actually took part.

Started

Aug 2012

Finished

Feb 2020

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 21 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria - Transplant Recipients: * At least 2 years of age and less than or equal to 21 years of age. * Histologically confirmed solid tumor or lymphoma at original diagnosis: * Ewing Sarcoma Family of Tumors (ESFT) * Gastrointestinal tumors * Germ Cell tumors * Hepatic tumors (including hepatocellular carcinoma and hepatoblastoma) * Lymphoma (including Hodgkin and non-Hodgkin lymphoma) * Kidney tumors (including Wilms tumor, rhabdoid tumors, clear cell carcinoma, and renal cell carcinoma) * Melanoma * Neuroblastoma * Soft tissue sarcoma (including rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma) * Malignancy has no reasonable expectation of cure with available alternative salvage therapy. * Has a suitable human leukocyte antigen (HLA) haploidentical donor available. * At least two weeks since receipt of any biological therapy, chemotherapy, and/or radiation therapy. * Has recovered from all acute NCI Common Toxicity Criteria grade II-IV acute non-hematologic toxicities from prior therapy per the judgment of the PI. * Shortening fraction greater than or equal to 25%. * Creatinine clearance or glomerular filtration rate (GFR) greater than or equal to 50 mL/min/1.73 m2. * Pulse oximetry greater than or equal to 92% on room air * Alanine aminotransferase (ALT) and aspartate transaminase (AST) less than or equal to3 times the upper limit of the institution-established normal range. * Direct bilirubin less than or equal to 3.0 mg/dL. * Karnofsky or Lansky performance score of greater than or equal to 50. Exclusion Criteria - Transplant Recipients: * Newly diagnosed patients with no prior attempt at curative therapy. * Any primary or active central nervous system (CNS) malignancy, including metastatic disease. * Any active or prior malignant or pre-malignant condition of the bone marrow, excluding metastasis of the primary malignancy. * Prior allogeneic hematopoietic stem cell transplant. * Prior autologous stem cell transplant within previous 3 months. * Allergy to murine products or positive human anti-mouse antibody (HAMA). * (Female only) Known pregnancy (negative serum or urine pregnancy test to be conducted within 7 days prior to enrollment). * (Female only) Breast feeding. Inclusion Criteria - Donors: * At least 18 years of age. * Partially HLA matched family member. * Human immunodeficiency virus (HIV) negative. Exclusion Criteria - Donors: * (Female only) Known pregnancy (negative serum or urine pregnancy test to be conducted within 7 days prior to enrollment). * (Female only) Breast feeding.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • St. Jude Children's Research Hospital

    Memphis, Tennessee, 38105, United States

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Other studies related to the condition(s) this trial covers.