Clinical trial · Interventional
Ultra-Low Dose IL-2 Therapy as GVHD Prophylaxis in Haploidentical Allogeneic Stem Cell Transplantation
Ultra Low Dose IL-2 Therapy as GVHD Prophylaxis in Haploidentical Allogeneic Stem Cell Transplantation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Background: \- Stem cell transplantation from a partially matched donor can lead to graft-versus-host disease (GVHD). Researchers want to learn how to improve these transplantations. Objective: \- To see if very low doses of Interleukin-2 after a partially matched transplantation prevent GVHD. Eligibility: * Recipients: age 18 65, with certain bone marrow or lymphatic system diseases and an available family member with partial tissue match. * Donors: age 18 80. Design: * Recipients will be screened with medical history, physical exam, and many tests including blood and tissue tying. * Donors will be screened with medical history, physical exam, blood tests and tissue typing. * Recipients will stay in the hospital 3 6 weeks. * All participants will have apheresis. Blood is drawn from one arm, run through a machine that collects white blood cells, then returned into the other arm. * Recipients will have: * Intravenous (IV) line placed under the skin and into a neck vein, to stay throughout transplant and recovery. They may also have a catheter inserted for collecting immune cells. * Bone marrow sample taken by needle. They will have 3 more after transplant. * Donors will have: * Filgrastim injected once daily for 5 6 days. * Stem and immune cells collected by another apheresis. * Recipients will get: * Eight 30-minute doses of radiation, sitting at a machine. * Donor immune cells by IV, 6 days before the transplant day. * Chemotherapy drugs by IV. \<TAB\>\<TAB\>- Donor stem cells by IV on transplant day. * After transplant, recipients will give self-injections of very low doses of Interleukin-2 once daily for about 12 weeks. * Before and after transplant, recipients will get medicine to suppress the immune system and antibiotics to prevent infections * Recipients must stay near NIH for 3 6 months after transplant. * All recipients and donors will have 3 years of follow-up.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia (ALL) | Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.80 |
| Acute Myelogenous Leukemia (AML) | Acute Myeloid Leukemia | ALIAS | 0.85 |
| Chronic Lymphocytic Leukemia (CLL) | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
| Chronic Myelogenous Leukemia (CML) | Chronic Myeloid Leukemia, BCR-ABL1 Positive | CURATED_BROADER | 0.80 |
| MDS | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CliniMACS CD34 selection system | Device | — | UNRESOLVED |
| ULD IL-2 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Subjects will receive CD34-selected stem cells followed by fixed dose ULG IL-2 (100,000 IU/m2) given subcutaneously for 12 weeks+Sirolimus until Day +60
- interventionNames
- Device: CliniMACS CD34 selection system
- Biological: ULD IL-2
Primary outcomes (1)
- measure
- Safety of ULD IL-2 as GVHD proph
- timeFrame
- 4 months
- description
- The primary endpoint to this study is to evaluate the safety of ULD IL-2 as GVHD prophylaxis in haploidentical transplantation.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
* INCLUSION CRITERIA RECIPIENT:
* Ages 18-70 years inclusive
* Haploidentical donor available
* Any one of the following hematologic conditions meeting a standard indication for allogeneic stem cell transplant:
* Chronic myelogenous leukemia (CML): Subjects under the age of 21 in chronic phase OR subjects ages 18-65 in chronic phase who have failed treatment with imatinib or have intolerance to imatinib OR Subjects ages 18-65 in accelerated phase or blast transformation. OR
* Acute lymphoblastic leukemia (ALL): any of these categories: Adult ALL including standard risk. All second or subsequent remissions, primary induction failure, partially responding or untreated relapse. OR
* Acute myelogenous leukemia (AML): AML in first remission - except AML with good risk karyotypes: AML M3 (t15; 17), AML M4Eo (inv 16), c-kit unmutated AML t (8; 21). All AML in second or subsequent remission, primary induction failure and resistant relapse. OR
* Myelodysplasticsyndromes(MDS): any of these categories - refractory anemia with transfusion dependence, refractory anemia with ANC\<500/ (Micro)L, refractory anemia with excess of blasts, transformation to acute leukemia, chronic myelomonocytic leukemia, atypical MDS/myeloproliferative syndromes. OR
* Myeloproliferative disorders including atypical (Ph-negative) chronic myeloid and neutrophilic leukemias, progressing myelofibrosis, and polycythemia vera, essential thrombocythemia either in transformation to acute leukemia or with progressive transfusion requirements or pancytopenia. OR
* Non-Hodgkin s lymphoma including Mantle cell lymphoma relapsing or refractory to standard of care treatments. OR
* Multiple myeloma, Waldenstroms macroglobulinemia, unresponsive or relapsed following standard of care treatments. OR
* Hodgkin's Lymphoma relapsing following an autologous transplant. OR
* Other rare hematologic malignancies for which hematopoietic stem cell transplantation has been performed and offers a durable remission or as the only option with a potential for cure.
* Chemotherapy-resistant multisystem Langerhans cell histiocytosis (MSLCH) especially involving organs like the bone marrow, liver, spleen, and lungs
* Aggressive systemic mastocytosis, and mast cell leukemia (MCL) in first CR (CR1)
* Hypereosinophilic syndrome who have failed imatinib therapy or FIP1L1-PDGFRa-negative patients who develop end-organ dysfunction
* Adult T-cell leukemia/lymphoma at first diagnosis
* Refractory or disseminated nasal-type extranodal NK/T-lymphoma or aggressive Natural killer cell leukemia/lymphoma
* Mycosis fungoides and S(SqrRoot)(Copyright)zary syndrome after failure of two or three initial therapies
* Primary or relapsed refractory Angioimmunoblastic T-cell lymphoma at first diagnosis
* Hepatosplenic T-cell lymphoma (gamma/delta T-cell lymphoma) at first diagnosis
* T-cell prolymphocytic leukemia at first diagnosis
* Subcutaneous panniculitic T-cell lymphoma at first diagnosis
* Hematodermic neoplasm (blastic natural killer cell lymphoma or Blastic plasmacytoid dendritic cell neoplasm) at first diagnosis
* Ability to comprehend the investigational nature of the study and provide informed consent.
EXCLUSION CRITERIA RECIPIENT (ANY OF THE FOLLOWING):
* HLA identical (6/6) related or (8/8 allele level matched) unrelated donor available and readily accessible at time of transplantation evaluation
* Major anticipated illness or organ failure incompatible with survival from transplant
* Severe psychiatric illness or mental deficiency sufficiently severe as to make compliance with the transplant treatment unlikely and making informed consent impossible.
* Positive pregnancy test for women of childbearing age
* Contraindication to receive IL-2 including:
* Hypersensitivity to IL-2
* Sustained ventricular tachycardia (\>5 beats)
* Cardiac arrhythmias not controlled or unresponsive to management
* Chest pain with ECG changes, consistent with angina or myocardial infarction
* Cardiac tamponade
* Intubation for \>72 hours
* Renal failure requiring dialysis \>72 hours
* Coma or toxic psychosis lasting \> 48 hours
* Repetitive or difficult to control seizures
* Active bowel ischemia or perforation
* Active GI bleeding requiring surgery
* DLCO adjusted for Hb and ventilation\< 50% predicted
* Left ventricular ejection fraction \< 40% (evaluated by ECHO) or \< 30% (evaluated by MUGA)
* AST/SGOT \> 5 times ULN
* Total bilirubin \> 3 times ULN
* Estimated GFR \<60ml/min (calculated by CKD-EPI, a formula routinely used in Clinical Research Center at National Institutes of Health. In case of borderline estimated GFR, CKD-EPI creatinine-cystatin C formula will be used for more accurate estimation)
* Prior allogeneic stem cell transplantation
INCLUSION CRITERIA DONOR:
* Related donor who shares 1 haplotype with the recipient
* Age greater than or equal to 18 or less than or equal to 80 years old
* Ability to comprehend the investigational nature of the study and provide informed consent.
EXCLUSION CRITERIA DONOR (ANY OF THE FOLLOWING):
* Unfit to receive G-CSF and undergo apheresis such as abnormal blood counts, history of stroke, uncontrolled hypertension
* Sickling hemaglobinopathy including HbSS, HbAS, HbSC
* Donors who are positive for HIV, active hepatitis B (HBV), hepatitis C (HCV) or human T-cell lymphotropic virus (HTLV-I/II)
* Severe psychiatric illness. Mental deficiency sufficiently severe as to make compliance with the BMT treatment unlikely and making informed consent impossible.References
Publications (3)
- BACKGROUNDGrosso D, Carabasi M, Filicko-O'Hara J, Kasner M, Wagner JL, Colombe B, Cornett Farley P, O'Hara W, Flomenberg P, Werner-Wasik M, Brunner J, Mookerjee B, Hyslop T, Weiss M, Flomenberg N. A 2-step approach to myeloablative haploidentical stem cell transplantation: a phase 1/2 trial performed with optimized T-cell dosing. Blood. 2011 Oct 27;118(17):4732-9. doi: 10.1182/blood-2011-07-365338. Epub 2011 Aug 25. PMID 21868572
- BACKGROUNDBarrett J, Gluckman E, Handgretinger R, Madrigal A. Point-counterpoint: haploidentical family donors versus cord blood transplantation. Biol Blood Marrow Transplant. 2011 Jan;17(1 Suppl):S89-93. doi: 10.1016/j.bbmt.2010.10.024. No abstract available. PMID 21195317
- BACKGROUNDFuchs EJ. Haploidentical transplantation for hematologic malignancies: where do we stand? Hematology Am Soc Hematol Educ Program. 2012;2012:230-6. doi: 10.1182/asheducation-2012.1.230. PMID 23233586