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Chemotherapy- or radiotherapy-predominant conditioning regimens in Single myeloablative unrelated umbilical cord blood transplantation for malignant hematological disease: a multicenter, controlled tr

Chemotherapy- or radiotherapy-predominant conditioning regimens in Single myeloablative unrelated umbilical cord blood transplantation for malignant hematological disease: a multicenter, controlled tr

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONRC-11001430
Enrollment
Unknown
Registered
2011-06-28
Start date
2011-09-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute leukemia, Myelodysplastic syndrome, chronic myeloid leukemia, malignant lymphoma

Interventions

A:Total-body radiotherapy-predominant conditioning regimens
B:chemotherapy-predominant conditioning regimens

Sponsors

Anhui Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 2-50 yrs; 2. No severe organ dysfunction or active infection; 3. Patients with acute leukemia that meet the criteria for unrelated umbilical cord blood transplantation (CR1 for patients with high risk or moderate risk without HLA-matched sibling donor; CR2 for patients with standard risk) and those with refractory leukemia (failed to fulfil CR after two standard treatment course); 4. Patients with Myelodysplastic syndrome: in blast or accelerating phase (CR2 after treated by tyrosine kinase inhibitor or chemotherapy), CP1(patients and their family insist to get unrelated umbilical cord blood transplantation and sign the informed consent, who cannot receive tyrosine kinase inhibitor nor have no HLA-matched sibling donor), and the spleen shrink and become unreachable on the rib margin; 5. Malignant lymphoma: stage III to IV (CR1 or CR2 without HLA-matched sibling donor).

Exclusion criteria

Exclusion criteria: 1. Refractory acute leukemia (no relief after 3 standard treatment course), progressing phase (blast cell + immature cells >30%); patients in blast phase of chronic myeloid leukemia did not response to tyrosine kinase inhibitor or have huge spleen; patients with uncontrolled meningeal leukemia; 2. Patients with any one of following active infections: active phase of TB, hepatitis B, or HBV-DNA>=105/copy, uncontrolled invasive fungal infection, sepsis, HIV; 3. Patients with organ dysfunction or be unstable: A: Cardiovascular system a. Uncontrolled hypertension, severe cardiac arrhythmia that require medication, cerebrovascular accident, stroke, MI (within 6 months), unstable agina (CCS stage>=4), thrombosis. b. cardiac ejection fraction<50%. B: Lung a. DLCO<40% or FEV1.0%<60%, or VO2/kg<20ml/kg. b. Active lesion; nodular lesion found by imaging. C: Liver: active hepatic disease or dysfunction. D: Kidney: elevated serum creatinine or Ccr<60ml/min. E: Karnofsky score<70. 4. Used cytotoxic drugs 2 weeks before conditioning regimens, except hydroxyurea, chlorambucil, thalidomide, imatinib mesylate and rituximab.

Design outcomes

Primary

MeasureTime frame
Count of blood cells;Detection of Engraftment Evidence;Classfication of bone marrow cells;liver function;CMV-DNA;Dectation of minimal residual disease;

Countries

China

Contacts

Public ContactZimin Sun
zmsun_vip@163.com+86 13605518126

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026