Evidence map›Paper›PMID 22491731›Full record

Trial reportHaematologica2012

Haploidentical allogeneic hematopoietic cell transplantation in adults using CD3/CD19 depletion and reduced intensity conditioning: a phase II study.

Birgit Federmann, Martin Bornhauser, Christoph Meisner, Lambros Kordelas, Dietrich W Beelen, Gernot Stuhler, Matthias Stelljes, Rainer Schwerdtfeger, Maximilian Christopeit, Gerhard Behre and 6 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Haematologica, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00202917 (Multicenter Phase I/II Study of Haploidentical Hematopoietic Cell Transplantation With CD3/CD19 Depleted Grafts in Patients With Treatment Refractory Hematologic Malignancies), which is not on this map. Cited by 50 papers.

0numbers the graph read from it
0cells of the map it votes in
50citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00202917 phase1 / phase2completednot on this map

Multicenter Phase I/II Study of Haploidentical Hematopoietic Cell Transplantation With CD3/CD19 Depleted Grafts in Patients With Treatment Refractory Hematologic Malignancies

TypeinterventionalSponsorUniversity Hospital TuebingenRan2004 to 2010Enrolled61ConditionsHematologic MalignanciesArmsFludarabine, Thiotepa, Melphalan, OKT-3, CD3/CD19 depletion on CliniMACS
3 · Its place in the literature

Who cites it

50 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Review
  8. Article
  9. Review
  10. Article
  11. Review
  12. Article
  13. Article
  14. Article
  15. Review
  16. Article
  17. Article
  18. Review
  19. Long-Term Mixed Chimerism AfterFrontiers in oncology · 2021
    Article
  20. T-Cell-Replete VersusFrontiers in pediatrics · 2021
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Birgit FedermannMedical Center, Department of Hematology & Oncology, University of Tuebingen, Tuebingen, Germany.
Martin Bornhauser
Christoph Meisner
Lambros Kordelas
Dietrich W Beelen
Gernot Stuhler
Matthias Stelljes
Rainer Schwerdtfeger
Maximilian Christopeit
Gerhard Behre
Christoph Faul
Wichard Vogel
Michael Schumm
Rupert Handgretinger
Lothar Kanz
Wolfgang A Bethge

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe report a prospective multicenter phase II study of haploidentical hematopoietic stem cell transplantation using CD3/CD19-depleted grafts after reduced intensity conditioning with fludarabine, thiotepa, melphalan and OKT-3. DESIGN AND

methodsSixty-one adults with a median age of 46 years (range 19-65 years) have been enrolled. Diagnoses were acute myeloid leukemia (n=38), acute lymphoblastic leukemia (n=8), non-Hodgkin's lymphoma (n=6), myeloma (n=4), chronic myeloid leukemia (n=3), chronic lymphatic leukemia (n=1) and myelodysplastic syndrome (n=1). Patients were considered high risk because of refractory disease (n=18), cytogenetics (n=6), complete remission (≥ 2) (n=9), chemosensitive relapse in partial remission (n=4) or relapse after prior hematopoietic stem cell transplantation (n=15 allogeneic, n=8 autologous, n=1 both). At haploidentical hematopoietic stem cell transplantation, 30 patients were in complete remission and 31 in partial remission. Grafts contained a median of 7.0 × 10(6) (range 3.2-22) CD34(+) cells/kg, 4.2 × 10(4) (range 0.6-44) CD3(+) T cells/kg and 2.7 × 10(7) (range 0.00-37.3) CD56(+) cells/kg.

resultsEngraftment was rapid with a median of 12 days to granulocytes more than 0.5 × 10(9)/L (range 9-50 days) and 11 days to platelets more than 20 × 10(9) (range 7-38 days). Incidence of grade IIIV acute graft-versus-host-disease and chronic graft-versus-host-disease was 46% and 18%, respectively. Non-relapse mortality on Day 100 was 23% and 42% at two years. Cumulative incidence of relapse/progression at two years was 31%. Kaplan-Meier estimated 1-year and 2-year overall survival with median follow up of 869 days (range 181-1932) is 41% and 28%, respectively.

conclusionsThis regimen allows successful haploidentical hematopoietic stem cell transplantation with reduced intensity conditioning in high-risk patients lacking a suitable donor. (clinicaltrials.gov identifier:NCT00202917).

Indexed as

Antigens, CD19CD3 ComplexHematopoietic Stem Cell TransplantationLymphocyte DepletionTransplantation ConditioningAdultAgedAntigens, CD34ChimerismFemaleGraft SurvivalGraft vs Host DiseaseHaplotypesHematologic DiseasesHematopoietic Stem CellsHumansAntigens, CD19Antigens, CD34CD3 ComplexReceptors, KIR

Identifiers

PMID22491731
PMCPMC3487553

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.