Clinical trial · Interventional
Palifermin in Preventing Oral Mucositis Caused by Chemotherapy and/or Radiation Therapy in Young Patients Undergoing Stem Cell Transplant
A Group-Wide Double-Blind Randomized Placebo-Controlled Trial of Palifermin to Prevent Chemotherapy and/or Radiotherapy Induced Oral Mucositis in Children Undergoing Autologous or Allogeneic Hematopoietic Stem Cell Transplantation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Withdrawn
Summary
Brief summary (as posted)
This randomized phase II trial is studying palifermin to see how well it works compared with a placebo in preventing oral mucositis caused by chemotherapy and/or radiation therapy in young patients undergoing stem cell transplant. Palifermin may help relieve or prevent oral mucositis caused by chemotherapy and radiation therapy in young patients undergoing stem cell transplant.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Mucositis | — | UNRESOLVED | — |
| Malignant Neoplasm | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Palifermin | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (palifermin)
- description
- Patients receive palifermin IV once daily for 3 days prior to chemotherapy and/or radiotherapy in the absence of unacceptable toxicity. Patients then receive palifermin IV on days 0, 1, and 2 after autologous or allogeneic hematopoietic stem cell transplantation.
- interventionNames
- Drug: Palifermin
- type
- PLACEBO_COMPARATOR
- label
- Arm II (placebo)
- description
- Patients receive placebo IV once daily for 3 days prior to chemotherapy and/or radiotherapy in the absence of unacceptable toxicity. Patients then receive placebo IV on days 0, 1, and 2 after autologous or allogeneic hematopoietic stem cell transplantation.
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 16 Years
Show eligibility criteria text
Criteria: * Patients undergoing myeloablative autologous or allogeneic hematopoietic stem cell transplantation (HSCT) for any indication * Any type of myeloablative HSCT conditioning regimen allowed * Patients undergoing allogeneic HSCT may undergo 1 of the following types of donor stem cells: 1. HLA-matched sibling or parent 2. Partially matched family donor (mismatched for a single HLA locus \[class I\]) 3. Fully matched unrelated marrow or peripheral blood stem cell donor 4. HLA-matched or partially mismatched (at least 4 of 6 match) cord blood (class I or II) * Fertile patients must use effective contraception * No HIV positivity * No known sensitivity to any E. coli-derived products 1. Known grade 1 to 2 allergic reactions to asparaginase allowed 2. No prior grade 3-4 allergies to asparaginase or pegaspargase * More than 30 days since prior and no concurrent treatment with any of the following therapies: 1. Oral cryotherapy 2. Glutamine as an oral supplement 3. Traumeel 4. Gelclair 5. Oral vancomycin paste 6. Low-level laser therapy 7. An investigational product or device in another clinical trial * No prior palifermin or other keratinocyte growth factors * No other concurrent cytotoxic drugs for conditioning or graft-vs-host disease prophylaxis (intrathecal methotrexate or cytarabine for CNS involvement allowed) * Not pregnant or nursing
References
Publications (0)
Data not yet available